Medical Intelligence

FDA-Cleared AI Medical Device Tracker

What’s entering your clinical environment, specialty by specialty

Every FDA 510(k) and PMA clearance for AI-powered medical devices — filtered to your specialty, with plain-English summaries written for clinicians, not regulators. Updated automatically via OpenFDA.

The FDA-Cleared AI Medical Device Tracker is a real-time, specialty-filtered database of every 510(k) and PMA clearance for AI-powered medical devices — with plain-English summaries written for clinicians, not regulators. New AI-enabled devices are cleared by the FDA every week, and most clinicians find out long after the fact. This tracker closes that gap. Know what’s entering your clinical environment before it shows up in a vendor pitch or a department meeting.

How to use it

  • Filter by specialty to see only what’s relevant to your practice
  • Check the plain-English summary before reading the regulatory filing
  • Bookmark and check back weekly — updated automatically as clearances are issued

81

Devices tracked

May

05/21/26

Latest clearance

7

Specialties covered

81 devices

RadiologyOncologyGeneral PracticeNew05/21/2026

BAC

DeepHealth, Inc.·FDA 510(k)·Detection / Diagnosis AI

BAC is an AI-powered software platform designed to assist radiologists in reading breast imaging studies such as mammograms. It uses machine learning algorithms to flag areas of concern, helping clinicians prioritize and review potentially significant findings. It is intended for use in breast imaging centers and radiology departments as a decision-support tool alongside conventional interpretation.

Why it mattersBreast cancer detection accuracy is highly dependent on reader experience and workload, and subtle findings can be missed under high-volume conditions. AI-assisted detection tools like BAC can serve as a second reader, reducing false negatives and helping less experienced radiologists catch findings they might otherwise overlook. This has the potential to improve early detection rates and reduce recall variability across practice settings.

BAC integrates into the radiology reading workflow as a concurrent or pre-read AI layer, surfacing flagged regions of interest so radiologists can focus their attention efficiently without replacing their final interpretive judgment.

K Number K254131Product Code QIHCategory Computer-Aided DetectionReview Panel RAReceived 12/22/2025
RadiologyOrthopedicsEmergency MedicineNew05/21/2026

MSK Go

Smart Alfa Teknoloji San. Ve Tic. A.S.·FDA 510(k)·Detection / Diagnosis AI

MSK Go is a cleared software platform designed to analyze musculoskeletal (MSK) imaging studies, such as X-rays or similar radiographic data, to assist radiologists and orthopedic clinicians in identifying relevant findings. The product code QIH is associated with computer-aided detection software for musculoskeletal applications. It operates as a software-as-a-medical-device (SaMD) that integrates into the diagnostic imaging workflow to flag or characterize MSK abnormalities.

Why it mattersMusculoskeletal conditions are among the most common reasons patients seek care, yet subtle findings on plain radiographs can be missed, particularly in high-volume or time-pressured settings. A decision-support tool in this space can reduce missed fractures, degenerative changes, or other pathology, potentially improving diagnostic accuracy and reducing downstream costs. For orthopedic and emergency settings, faster and more reliable MSK reads can meaningfully impact triage and treatment planning.

MSK Go would integrate into the radiology or orthopedic imaging workflow at the point of image review, providing automated analysis alongside standard reads to support or expedite clinician interpretation without replacing physician judgment.

K Number K260234Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 01/26/2026
RadiologyNeurologyOncologyNew05/18/2026

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

Cercare Medical A/S·FDA 510(k)·Detection / Diagnosis AI

CMN Capillary Function with Virtual Expert is a post-processing software platform that takes perfusion imaging from MRI, CT, or CBCT and extracts quantitative measures of capillary transit heterogeneity and microvascular function. Unlike traditional perfusion maps (CBF, CBV, MTT), it targets capillary-level dysfunction, which can reflect tissue at risk even when conventional maps appear normal. The 'Virtual Expert' component provides automated interpretation guidance, helping clinicians contextualize findings without requiring deep perfusion analysis expertise.

Why it mattersCapillary dysfunction is an early and sensitive marker of tissue injury in stroke, brain tumors, and neurodegenerative conditions, but it has historically required specialized expertise to interpret. This tool democratizes advanced perfusion analysis by automating the extraction and interpretation of capillary biomarkers, potentially enabling earlier identification of ischemic penumbra, treatment response in neuro-oncology, or vascular compromise. For centers without dedicated neuroradiology perfusion expertise, it could meaningfully close a diagnostic gap.

The software integrates into existing imaging workflows across MRI, CT, and CBCT platforms, automatically generating capillary function maps and interpretive outputs alongside standard perfusion data  reducing the manual post-processing burden and providing decision support at the point of image review.

K Number K253831Product Code LLZCategory Image Analysis SoftwareReview Panel RAReceived 12/01/2025
RadiologyNeurologyNuclear MedicineNew05/15/2026

Neurophet SCALE PET

Neurophet., Inc.·FDA 510(k)·Image Segmentation

Neurophet SCALE PET is an AI-powered software platform that processes brain PET scans to automatically segment brain regions and quantify radiotracer uptake across those regions. It standardizes and scales the PET signal to allow meaningful comparisons across scans and patients. It is designed for use in clinical neuroimaging workflows where PET is used to evaluate conditions such as Alzheimer's disease or other neurodegenerative disorders.

Why it mattersAccurate quantification of brain PET uptake is technically demanding and historically dependent on reader experience and manual processing steps that introduce variability. By automating segmentation and scaling, this tool reduces inter-reader variability and makes quantitative PET analysis more accessible and reproducible across clinical settings. This can improve diagnostic consistency and support earlier, more confident identification of neurodegenerative pathology.

This software integrates into the neuroimaging PET reporting workflow, automatically processing scans and delivering quantified regional uptake data to the interpreting clinician, reducing manual post-processing time and enabling faster, standardized reads.

K Number K252563Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 08/14/2025
RadiologyNeurologyOncologyNew05/15/2026

SubtleHD-CT (1.x)

Subtle Medical, Inc.·FDA 510(k)·Image Reconstruction / Enhancement AI

SubtleHD-CT is a deep learning-based post-processing tool that takes standard CT images and outputs higher-quality, lower-noise versions of those images. It applies AI algorithms trained on large imaging datasets to sharpen detail and reduce artifacts without requiring changes to scanner hardware or acquisition protocols. It is designed for use in radiology departments as part of the standard image review workflow.

Why it mattersNoise reduction in CT imaging has traditionally required trade-offs  either higher radiation dose or accepted image degradation. SubtleHD-CT allows radiologists to work with cleaner images from existing acquisitions, potentially improving detection of subtle findings without additional dose burden to the patient. This is particularly relevant in dose-sensitive populations such as pediatric or repeat-scan oncology patients.

The software integrates into the existing PACS or reconstruction pipeline, processing images automatically before they reach the radiologist's workstation, adding minimal friction while delivering enhanced image quality for interpretation.

K Number K254120Product Code QIHCategory Image Enhancement SoftwareReview Panel RAReceived 12/19/2025
RadiologyNeurologyPsychiatryNew05/15/2026

Neurophet AQUA

Neurophet., Inc.·FDA 510(k)·Image Segmentation

Neurophet AQUA is an AI-powered brain MRI analysis platform that automatically segments and measures volumes of discrete brain regions from structural MRI images. It processes MRI data to generate quantitative volumetric reports of structures such as the hippocampus, cortical regions, and white matter. It is designed for use in radiology and neurology settings where objective brain morphometry can support clinical decision-making.

Why it mattersManual or subjective visual assessment of brain atrophy on MRI is highly variable and time-consuming; automated volumetric quantification provides objective, reproducible measurements that can support earlier and more confident diagnosis of conditions like Alzheimer's disease and other dementias. By delivering standardized brain volume metrics, it reduces reliance on qualitative eyeballing and gives clinicians a consistent benchmark for monitoring disease progression over time.

AQUA integrates into the neuroimaging workflow by automatically processing uploaded MRI studies and returning structured volumetric reports, enabling radiologists and neurologists to incorporate quantitative brain morphometry into routine reads without manual segmentation effort.

K Number K261273Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 04/17/2026
OrthopedicsNeurologySurgeryNew05/15/2026

UNiD™ Spine Analyzer (SW3002)

Medicrea International S.A.S. (Medtronic)·FDA 510(k)·Predictive Analytics

UNiD Spine Analyzer is a spine-specific surgical planning software that processes patient imaging to measure spinal alignment parameters and model optimal rod geometry and implant configuration. It uses patient-specific data to help surgeons plan corrective spinal procedures, particularly for deformity cases. The software integrates with the UNiD patient-specific rod manufacturing workflow, translating the surgical plan into custom-bent implants.

Why it mattersAchieving optimal sagittal and coronal spinal alignment is one of the most technically demanding aspects of deformity surgery, and misalignment is a leading driver of adjacent segment disease and reoperation. By providing quantitative, patient-specific alignment targets and predictive modeling, this tool reduces reliance on intraoperative estimation and supports more consistent alignment outcomes. It also closes the loop between planning and implant production, enabling rods to be pre-bent to the planned correction before the patient enters the OR.

Surgeons input preoperative imaging data into the software during the planning phase; the analyzed alignment parameters and rod specifications are then used to manufacture patient-specific implants ahead of the scheduled procedure, streamlining intraoperative execution and reducing manual rod bending.

K Number K261289Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 04/20/2026
RadiologyOncologyNeurologyNew05/14/2026

SubtleHD-PET (1.x)

Subtle Medical, Inc.·FDA 510(k)·Image Reconstruction / Quality Enhancement

SubtleHD-PET uses deep learning algorithms to enhance the spatial resolution and overall image quality of PET scans after acquisition. Rather than requiring changes to scanner hardware or acquisition protocols, it processes existing PET data to produce sharper, higher-definition images. It is designed for integration into the radiology or nuclear medicine reading workflow, improving diagnostic confidence without additional patient radiation dose.

Why it mattersLow-resolution or noisy PET images can obscure small lesions, reduce diagnostic confidence, and lead to equivocal reads  particularly in oncologic staging, neurologic evaluation, and treatment response assessment. By enhancing image sharpness post-acquisition, this tool may improve detection of subtle findings without requiring longer scan times or higher radiotracer doses. This is especially valuable in patients where dose reduction is a priority, such as pediatric or frail populations.

The software integrates into existing PET reading workflows as a post-processing step, delivering enhanced images to the reading workstation without disrupting scanner protocols or requiring technologist retraining, allowing radiologists and nuclear medicine physicians to read higher-quality studies within their standard routine.

K Number K254013Product Code LLZCategory Image Enhancement SoftwareReview Panel RAReceived 12/15/2025
RadiologyNeurologyOncologyNew05/13/2026

Morph

BeauBrain Healthcare, Inc.·FDA 510(k)·Image Segmentation

Morph is an image analysis software cleared by the FDA under product code QIH, which is associated with radiological computer-aided detection and diagnosis tools. Developed by BeauBrain Healthcare, the device is designed to process medical imaging data  most likely brain MRI  to identify, segment, or quantify anatomical structures or pathological findings. It is intended for use in clinical radiology or neurology settings where precise image-based measurements inform diagnosis or treatment decisions.

Why it mattersAccurate segmentation of neurological structures on imaging is time-consuming and subject to inter-reader variability when done manually. A tool like Morph can standardize measurements, reduce radiologist workload, and provide reproducible quantitative data that supports clinical decision-making in conditions such as brain tumors, neurodegeneration, or structural abnormalities. This can be especially impactful in longitudinal monitoring where subtle changes over time need to be reliably detected.

Morph integrates into the imaging review process by automating or assisting with segmentation tasks, allowing radiologists and neurologists to receive structured, quantitative outputs alongside standard imaging studies without significantly disrupting existing PACS-based workflows.

K Number K260032Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 01/06/2026
General PracticeRadiologyNew05/11/2026

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.·FDA 510(k)·Detection / Diagnosis AI

V4D Endo-Perio is an AI-assisted image analysis tool that reviews dental X-rays to identify endodontic findings (such as periapical lesions and root canal anatomy) and periodontal findings (such as bone loss patterns). It is designed for use chairside or within a dental practice workflow, providing automated detection support to general dentists and specialists. The software analyzes uploaded radiographic images and highlights areas of clinical concern for clinician review and confirmation.

Why it mattersEndodontic and periodontal pathology can be subtle on standard dental radiographs, and early findings are frequently missed or inconsistently characterized across providers. An AI-assisted detection layer helps reduce diagnostic variability, surfaces findings that might otherwise be overlooked, and supports less experienced clinicians in making more consistent assessments. This can lead to earlier treatment intervention and better documentation of disease progression over time.

The software integrates into the dental imaging workflow, automatically flagging endo and perio findings on radiographs so clinicians can prioritize review and act on AI-generated detections without adding significant time to the appointment.

K Number K252953Product Code MYNCategory Image Analysis SoftwareReview Panel RAReceived 09/16/2025
OrthopedicsRadiologyNew05/08/2026

HipGuide (V 1.0.0.0)

Orthopedic Driven Imaging, LLC·FDA 510(k)·Image Segmentation

HipGuide is an image analysis software platform designed to evaluate hip radiographs or imaging data, automatically identifying anatomical landmarks and generating clinically relevant measurements of the hip joint. It is intended for use in orthopedic clinical settings to support assessment of hip pathology and pre-operative planning. The software processes imaging inputs and presents structured output to guide clinical decision-making.

Why it mattersAccurate hip measurements  such as acetabular coverage, femoral offset, and leg length discrepancy  are critical for diagnosing hip dysplasia, impingement, and planning total hip arthroplasty, but manual measurement is time-consuming and operator-dependent. HipGuide aims to standardize and accelerate this process, reducing variability between clinicians. For high-volume orthopedic practices, this could meaningfully improve pre-operative planning consistency and efficiency.

HipGuide integrates into the pre-operative or diagnostic imaging review workflow, allowing orthopedic surgeons to rapidly obtain standardized hip measurements without relying solely on manual radiographic templating or separate radiology consultation for routine geometric analysis.

K Number K260321Product Code LLZCategory Image Analysis SoftwareReview Panel RAReceived 01/30/2026
RadiologyGeneral PracticeNew04/23/2026

DS Core CBCT Anatomy

Dentsply Sirona·FDA 510(k)·Image Segmentation

DS Core CBCT Anatomy is a cloud-based or integrated software platform developed by Dentsply Sirona that processes CBCT scans to automatically delineate key anatomical structures such as teeth, bone, nerves, and sinuses. It uses automated image analysis to generate 3D anatomical models from raw CBCT data. This tool is designed for dental specialists and oral surgeons who rely on detailed spatial anatomy for treatment planning.

Why it mattersManual segmentation of CBCT data is time-consuming and operator-dependent, often requiring specialized training or outsourcing to third-party labs. Automated anatomical segmentation reduces this burden, enabling faster and more consistent treatment planning directly at the point of care. For clinicians performing implant placements, extractions, or orthognathic procedures, reliable nerve and structure identification can meaningfully reduce procedural risk.

This software integrates into the pre-procedural planning workflow by automatically generating anatomical overlays and 3D reconstructions from CBCT scans, reducing the time between imaging acquisition and actionable treatment planning without requiring manual segmentation steps.

K Number K260785Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 03/10/2026
OB/GYNRadiologyReproductive EndocrinologyNew04/20/2026

Folliscan

Mim Fertility·FDA 510(k)·Detection / Diagnosis AI

Folliscan is a software tool that automatically analyzes transvaginal ultrasound images to detect and measure ovarian follicles. Rather than relying solely on manual counting and caliper measurements by the sonographer, the software processes ultrasound images and provides standardized follicle assessments. It is designed for use in fertility clinics during ovarian stimulation monitoring for procedures such as IVF or IUI.

Why it mattersManual follicle counting and measurement is time-consuming, operator-dependent, and subject to inter-observer variability  inconsistencies that can affect treatment decisions like trigger timing or dose adjustments. Automated follicle analysis reduces that variability and can speed up the monitoring visit workflow, which is particularly impactful in high-volume fertility clinics where patients are seen daily during stimulation cycles. More consistent measurements may support more precise, individualized dosing decisions.

Folliscan integrates into the follicle monitoring ultrasound workflow, providing automated follicle detection and sizing that can reduce hands-on measurement time per patient and generate standardized reports to guide stimulation protocol adjustments.

K Number K252332Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 07/25/2025
RadiologyCritical Care04/14/2026

Critical Care Suite with Enteric Tube Positioning AI Algorithm

GE Medical Systems, LLC·FDA 510(k)·Automated Detection / Image Analysis

GE's AI algorithm analyzes chest X-rays in real time to confirm whether enteric (feeding) tubes are correctly positioned in critically ill patients. Tube misplacement in ICU settings is a known cause of serious patient harm  this tool provides an automatic safety check on routine images, flagging errors before feeding begins.

Why it mattersEnteric tube malposition is a preventable harm that occurs regularly in ICUs. This AI runs within GE's existing Critical Care Suite workflow, meaning critical care teams get an automated safety net without changing how they order or view X-rays. Earlier detection means faster clinical response and fewer adverse events.

Integrates into routine chest X-ray review in ICU and critical care settings. Relevant to radiologists interpreting ICU films, intensivists, critical care nurses, and any clinician verifying tube placement before initiating enteral feeds.

K Number K253502Product Code QIHCategory Computer-Aided Detection (CAD)Review Panel RadiologyReceived 10/30/2025
OncologyRadiology04/10/2026

AI-Rad Companion Organs RT

Siemens Healthcare GmbH·FDA 510(k)·Organ Segmentation / Treatment Planning AI

Siemens' AI software automatically outlines organs at risk  such as the heart, lungs, and spinal cord  from CT scans used in radiation therapy planning. Manually drawing these contours is one of the most time-consuming steps in RT planning. This AI performs the task in minutes rather than hours.

Why it mattersOrgan contouring for radiation therapy is a bottleneck that delays treatment start dates for cancer patients. Automated AI-driven contouring reduces planner burden, improves consistency across cases, and may enable faster access to radiation treatment. Radiation oncologists and dosimetrists will encounter this type of tool with increasing frequency.

Directly relevant to radiation oncology departments, dosimetrists, and medical physicists. Also relevant to radiologists providing imaging for RT planning. Affects workflow from simulation CT acquisition through treatment plan approval.

K Number K252548Product Code QKBCategory Radiation Therapy Planning SoftwareReview Panel RadiologyReceived 08/13/2025
RadiologyOrthopedicsSurgery04/10/2026

Relu Cloud

Relu BV·FDA 510(k)·Image Segmentation

Relu Cloud is a cloud-hosted medical image processing and visualization tool that allows clinicians to upload, segment, and analyze DICOM imaging data from any web-connected device. It is designed to convert standard CT or MRI scans into detailed 3D anatomical models and segmentations. It is used in radiology, orthopedics, and surgical planning workflows to improve anatomical understanding before procedures.

Why it mattersBy moving image segmentation and 3D reconstruction to the cloud, Relu Cloud removes the need for expensive on-site workstations or dedicated software installations, lowering the barrier for surgical planning and complex anatomical review. This enables broader access to advanced imaging analysis, particularly in resource-limited or decentralized care settings. Surgeons and radiologists can collaborate on cases remotely without sharing large raw image files.

Clinicians can access, segment, and visualize patient imaging data directly from a browser during pre-operative planning or case conferencing, reducing turnaround time and eliminating dependency on specialized hardware at each site.

K Number K252708Product Code QIHCategory Image Analysis SoftwareReview Panel DEReceived 08/27/2025
RadiologyGeneral Practice04/10/2026

Overjet Iris Intelligent Imaging System

Overjet, Inc.·FDA 510(k)·Detection / Diagnosis AI

Overjet Iris is an AI-driven image analysis tool that automatically reviews dental X-rays and overlays visual annotations highlighting areas of concern, such as cavities or alveolar bone loss. It processes radiographs in near real-time within the dental practice workflow, presenting findings directly on the image for the clinician to review. The system is intended to serve as a decision-support aid, not a replacement for clinical judgment.

Why it mattersDental radiograph interpretation can be subjective and variability between clinicians is well documented, particularly for early interproximal caries and early-stage bone loss. By providing a consistent, AI-generated second read, Overjet Iris can help reduce missed findings and support more standardized, evidence-based treatment planning. This is especially impactful in high-volume practices or settings where less experienced providers may benefit from automated guidance.

The system integrates into existing dental imaging workflows, automatically analyzing X-rays as they are acquired and displaying annotated findings on-screen during the patient visit, enabling real-time clinical decision support without requiring additional steps or interruptions to the encounter.

K Number K253930Product Code QIHCategory Computer-Aided DetectionReview Panel RAReceived 12/09/2025
CardiologyNeurology04/07/2026

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

Anumana, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

Anumana's AI reads a routine 12-lead ECG and flags patterns that may indicate cardiac amyloidosis  a protein accumulation disease that is frequently under-diagnosed until it has caused significant heart damage. The algorithm detects subtle waveform signatures that the human eye routinely misses during standard ECG review.

Why it mattersCardiac amyloidosis, particularly ATTR-CA, has historically been caught only in late stages. New disease-modifying therapies now exist and work best when started early  making early detection clinically actionable. An AI flag on a routine ECG already performed on millions of patients annually could become one of the most impactful screening tools in cardiology.

Relevant to cardiologists, internists, and primary care physicians who order or review ECGs. Can be integrated into existing ECG reporting systems. Particularly relevant to heart failure clinics and centers evaluating patients with unexplained cardiomyopathy.

K Number K253801Product Code SHPCategory ECG Analysis Software (SaMD)Review Panel CardiovascularReceived 11/28/2025
RadiologyEmergency MedicineOrthopedics04/01/2026

CoLumbo C-Spine

Smart Soft Healthcare AD·FDA 510(k)·Detection / Diagnosis AI

CoLumbo C-Spine is an AI-assisted software that analyzes cervical spine imaging studies  likely plain radiographs or CT scans  to flag potential fractures or structural abnormalities. It works by applying automated image analysis algorithms to highlight findings that may require clinical attention. This tool is intended for use in radiology reading workflows, particularly in high-volume or time-sensitive settings such as emergency departments.

Why it mattersMissed cervical spine fractures are among the most consequential diagnostic errors in emergency and trauma medicine, with potentially catastrophic neurological consequences. An AI-assisted detection tool can serve as a safety net, reducing the risk of overlooked findings especially during high-acuity, high-volume periods. This supports more consistent reads and may accelerate time-to-diagnosis for patients with traumatic neck injuries.

CoLumbo C-Spine integrates into the imaging review workflow, providing automated alerts or annotations on cervical spine studies to help radiologists and emergency clinicians prioritize and verify critical findings before finalizing reads.

K Number K254015Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 12/15/2025
CardiologySurgeryEmergency Medicine03/30/2026

IntelliVue Measurement Rack 6000 (867317)

Philips Medizin Systeme Böblingen GmbH·FDA 510(k)·Automated Measurement and Data Analysis

This is a bedside monitoring system that automatically captures and analyzes vital signs and cardiovascular measurements in real-time. It serves patients in ICUs, operating rooms, and acute care settings who require continuous physiologic monitoring. The system reduces manual measurement burden and helps clinicians detect changes in patient status more quickly.

Why it mattersAutomated vital sign monitoring decreases nursing workload and reduces errors from manual assessment, while enabling faster clinical response to hemodynamic instability. This is particularly important in high-acuity settings where real-time data fidelity directly impacts patient outcomes. Clinicians benefit from standardized, continuous measurement data that integrates seamlessly into electronic health records.

ICU nurses, anesthesiologists, and critical care physicians use this system during patient admission and throughout their stay to guide titration of vasopressors, fluid management, and other acute interventions.

K Number K253654Product Code MSXCategory Patient Monitoring and Measurement SystemReview Panel CardiovascularReceived 11/20/2025
RadiologySurgeryOncology03/30/2026

Avatar Medical Vision

Avatar Medical·FDA 510(k)·Image Segmentation

Avatar Medical Vision converts standard DICOM imaging studies  such as CT or MRI scans  into interactive, patient-specific 3D anatomical models. Clinicians can manipulate and explore these volumetric reconstructions in real time rather than interpreting stacked 2D slices. The platform is designed for use in radiology reading environments as well as pre-procedural planning across surgical specialties.

Why it mattersInterpreting complex anatomy from 2D cross-sectional images requires significant expertise and can miss spatial relationships that affect surgical approach. Immersive 3D visualization allows surgeons and radiologists to better understand patient-specific anatomy before procedures, potentially reducing intraoperative surprises. This is particularly valuable in oncologic resections, orthopedic reconstruction, and vascular cases where spatial orientation is critical.

This tool integrates into pre-procedural planning workflows, allowing radiologists and surgeons to collaborate around an interactive 3D model derived directly from the patient's existing imaging, without requiring additional scans or external 3D printing services.

K Number K253950Product Code LLZCategory Image Analysis SoftwareReview Panel RAReceived 12/10/2025
RadiologyVascular SurgeryCardiology03/30/2026

AiORTA - Plan v2.0

ViTAA Medical Solutions, Inc.·FDA 510(k)·Image Segmentation

AiORTA - Plan v2.0 is an AI-assisted planning software that processes CT imaging of the aorta to automatically segment the vessel and generate precise anatomical measurements. It is designed to support vascular surgeons and interventional radiologists in pre-procedural planning for aortic interventions such as EVAR or open repair. The software translates complex aortic anatomy into actionable morphometric data to guide device selection and procedural strategy.

Why it mattersAccurate aortic measurements are critical for selecting the correct endograft size and predicting procedural success, yet manual segmentation is time-consuming and operator-dependent. This tool reduces planning time and minimizes measurement variability, which can directly impact procedural outcomes and reduce the risk of endoleak or device mismatch. For busy vascular practices, automated aortic planning can streamline pre-op workflows and improve consistency across cases.

This software integrates into the pre-procedural planning phase, allowing clinicians to import CT aorta studies and obtain automated segmentation and measurements without lengthy manual contouring, freeing up time for clinical decision-making and case review.

K Number K254207Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 12/29/2025
PulmonologyCardiology03/28/2026

ECG-AI Pulmonary Hypertension (PH) 12-Lead Algorithm (1020)

Anumana, Inc.·FDA 510(k)·Pattern Recognition / Screening AI

Anumana's ECG-AI analyzes 12-lead ECGs for signs of pulmonary hypertension  elevated pressure in the arteries supplying the lungs. PH is notoriously difficult to diagnose early; patients often wait years for an accurate diagnosis. This AI applies to a test already routinely performed on patients with unexplained breathlessness.

Why it mattersPulmonary hypertension has a mean diagnostic delay of 2+ years. By the time most patients are diagnosed, significant right heart remodeling has occurred. An AI layer on routine ECGs could enable much earlier screening  especially in patients with unexplained dyspnea who might not otherwise be evaluated for PH.

Relevant to pulmonologists, cardiologists, and primary care physicians managing patients with unexplained breathlessness. The ECG is already part of most standard workups, making this a zero-friction screening addition when integrated into ECG reporting systems.

K Number K252360Product Code SATCategory ECG Analysis Software (SaMD)Review Panel CardiovascularReceived 07/29/2025
OB/GYNRadiology03/27/2026

Butterfly Gestational Age Tool

Butterfly Network, Inc.·FDA 510(k)·Gestational Age Estimation / Automated Biometric Measurement

This AI tool automatically measures key fetal biometric parameters on ultrasound and calculates estimated gestational age, reducing manual measurement time and variability. It supports OB/GYN and sonography teams in pregnancy dating and prenatal screening workflows. The tool helps standardize age estimation across different operators and clinical settings.

Why it mattersAccurate gestational age assessment is critical for prenatal care timing, risk stratification, and detecting growth abnormalities. Automating biometric measurements reduces operator dependence, improves reproducibility, and can accelerate point-of-care ultrasound workflows. This is especially relevant for portable ultrasound platforms like Butterfly's handheld systems.

OB/GYN clinicians and sonographers encounter this tool during routine prenatal ultrasound exams, particularly in the first and second trimester when biometric dating is most accurate and clinically important.

K Number K252148Product Code IYNCategory Diagnostic AI / Automated MeasurementReview Panel RadiologyReceived 07/09/2025
RadiologyOrthopedicsNeurology03/26/2026

SwiftMR

Airs Medical, Inc.·FDA 510(k)·Image Reconstruction / Enhancement AI

SwiftMR is a software platform that uses deep learning algorithms to reconstruct and enhance MRI images acquired with fewer data samples than traditional protocols require. By intelligently filling in image data, it allows MRI scans to be completed significantly faster without sacrificing diagnostic quality. It integrates into the existing MRI workflow and operates on images as they are acquired, delivering enhanced images directly to the radiologist's reading workstation.

Why it mattersMRI scan time is one of the most persistent bottlenecks in radiology departments, contributing to patient discomfort, motion artifacts, and limited scanner throughput. By accelerating acquisition without degrading image quality, SwiftMR can meaningfully increase the number of patients scanned per day and reduce the frequency of repeat scans due to motion. This has direct implications for department efficiency, patient access to MRI, and diagnostic confidence.

SwiftMR fits into the existing MRI acquisition pipeline without requiring significant protocol overhaul  technologists run abbreviated scans and the software automatically reconstructs diagnostic-quality images before they reach the radiologist, reducing turnaround time with minimal change to established workflow.

K Number K253775Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 11/26/2025
Neurology03/26/2026

REAL INTELLIGENCE" CORI"

Blue Belt Technologies, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

REAL INTELLIGENCE CORI uses machine learning to analyze neurological patient data and provide AI-assisted diagnostic insights for neurologists. The device is designed to help clinicians identify patterns and anomalies that may support diagnosis of neurological conditions. It augments clinical assessment during neurology consultations and workup.

Why it mattersThis device represents FDA clearance of a specialized neurology AI tool that can help reduce diagnostic variability and accelerate clinical decision-making in complex neurological cases. Neurologists should be aware of this cleared tool as a potential decision-support resource for patient evaluation and care planning.

Neurologists use REAL INTELLIGENCE CORI during patient evaluation and diagnostic workup to review and interpret neurological findings and test results, helping inform clinical assessment and next steps in care.

K Number K260601Product Code OLOCategory Diagnostic AIReview Panel NeurologyReceived 02/24/2026
RadiologyOncology03/13/2026

InferCare RECIST

Beijing Infervision Healthcare Medical Technology Co., Ltd.·FDA 510(k)·Detection / Diagnosis AI

InferCare RECIST automates the measurement and longitudinal tracking of tumors on CT scans using the standardized RECIST 1.1 framework. The software detects lesions, calculates their dimensions, and compares measurements across time points to determine disease response categories such as complete response, partial response, stable disease, or progressive disease. It is designed for use in radiology departments reading oncology cases where serial imaging is performed to monitor treatment efficacy.

Why it mattersManual RECIST measurements are time-consuming, prone to inter-reader variability, and represent a significant burden in high-volume oncology imaging practices. By automating lesion detection and measurement, this tool reduces the cognitive load on radiologists and improves consistency in treatment response reporting  which directly influences oncologists' decisions to continue, modify, or discontinue cancer therapy. Standardized, reproducible measurements also strengthen the quality of data used in clinical trials.

InferCare RECIST integrates into the radiology reading workflow by automatically populating lesion measurements and response assessments at the time of image review, reducing the manual steps required to generate structured oncology follow-up reports and enabling faster turnaround for oncology teams awaiting treatment response data.

K Number K252261Product Code QIHCategory Image Analysis SoftwareReview Panel RAReceived 07/21/2025
RadiologyOncologyGeneral Practice03/13/2026

Aeka Imaging

Good Methods Global, Inc.·FDA 510(k)·Detection / Diagnosis AI

Aeka Imaging is a diagnostic imaging software platform developed by Good Methods Global, Inc. It is designed to support clinicians in analyzing medical images by processing visual data to aid in clinical decision-making. The platform operates as a software-as-a-medical-device (SaMD) and is intended for use in clinical settings where image review and interpretation are part of the diagnostic workflow.

Why it mattersProduct code LLZ covers software intended for radiological image analysis, meaning this tool may help reduce the cognitive burden on radiologists by highlighting or organizing relevant findings during image review. If AI-assisted, it could help prioritize worklists or flag potential abnormalities, improving throughput and reducing diagnostic delays. Even without confirmed AI functionality, structured image analysis tools in this category can standardize interpretation and reduce variability across readers.

Aeka Imaging would integrate into the radiology or image review workflow, potentially functioning alongside or within a PACS environment to support image interpretation and reporting. Clinicians in radiology or referring specialties may use it to accelerate and structure their diagnostic process.

K Number K253111Product Code LLZCategory Image Analysis SoftwareReview Panel RAReceived 09/24/2025
Gastroenterology03/12/2026

Deep Capsule® (Deep Capsule US)

Digestaid - Artificial Intelligence Development SA·FDA 510(k)·Pattern Recognition / Diagnostic AI

Deep Capsule® uses artificial intelligence to analyze video frames from capsule endoscopy and help gastroenterologists identify potential lesions, polyps, and other abnormalities in the small bowel and GI tract. The software provides real-time or post-procedure detection assistance, reducing the cognitive burden on endoscopists reviewing lengthy capsule endoscopy recordings. This addresses the challenge of ensuring no clinically significant findings are missed during review of thousands of video frames per procedure.

Why it mattersCapsule endoscopy generates massive amounts of video data that can be fatiguing for clinicians to review manually, increasing the risk of missed pathology. AI-assisted detection improves diagnostic sensitivity and consistency while reducing procedural review time. Clinicians should be aware of this tool as it can enhance diagnostic accuracy and workflow efficiency in small bowel evaluation.

Gastroenterologists and endoscopy specialists encounter this software during or after capsule endoscopy procedures, using it to review and interpret the recorded video stream to identify and localize gastrointestinal lesions.

K Number K250655Product Code QZFCategory Computer-Aided Detection (CAD)Review Panel Gastroenterology, UrologyReceived 03/05/2025
CardiologyRadiologyEmergency Medicine03/02/2026

Clarius Ejection Fraction AI

Clarius Mobile Health Corp.·FDA 510(k)·Automated Quantification / Measurement AI

Clarius combines their handheld ultrasound device with AI that automatically calculates ejection fraction  the key measure of how well the heart is pumping  directly from a bedside scan. Traditionally, LVEF requires a formal echocardiogram with a skilled sonographer. This brings a clinically critical measurement to any bedside.

Why it mattersEjection fraction drives major clinical decisions: initiating heart failure therapy, risk-stratifying cardiac patients before procedures, and evaluating acutely ill patients. Moving this measurement to a bedside handheld device could expand access to cardiac assessment in emergency settings, ICUs, and resource-limited environments without waiting for echo lab scheduling.

Relevant to emergency physicians, hospitalists, intensivists, and cardiologists using point-of-care ultrasound. Reduces dependence on formal echo lab scheduling for initial EF assessment in acute and urgent settings.

K Number K253593Product Code QIHCategory Point-of-Care Ultrasound (POCUS) AIReview Panel RadiologyReceived 11/17/2025
RadiologyEmergency Medicine02/24/2026

AI Platform 2.2 (AIP002)

Exo Imaging·FDA 510(k)·Image Enhancement / AI-Assisted Interpretation

Exo Imaging's AI Platform enhances ultrasound image quality and provides automated interpretation assistance on their handheld POCUS device. The AI is designed to lower the skill floor for performing meaningful ultrasound at the bedside  helping non-radiologist clinicians produce and interpret diagnostic-quality images without specialist support.

Why it mattersPoint-of-care ultrasound is increasingly used across emergency medicine, critical care, and primary care, but image quality and interpretation accuracy remain highly operator-dependent. AI that enhances images and guides interpretation could democratize access to ultrasound-based diagnosis in settings without imaging specialists. Cleared via the expedited Special 510(k) pathway.

Relevant to emergency physicians, hospitalists, nurse practitioners, and any clinician trained in POCUS. Reduces the gap between operator experience levels at the bedside. The Special 510(k) pathway indicates this is an update to a previously cleared device.

K Number K260217Product Code QIHCategory AI-Enhanced Ultrasound PlatformReview Panel RadiologyReceived 01/23/2026
Orthopedics02/12/2026

Lumbar Spine Truss System - Plating Solution (LSTS-PS)

4Web, Inc.·FDA 510(k)·Not AI/ML-based

This is a traditional orthopedic implant (plating system for lumbar spine fusion) rather than an AI/ML-enabled device. It provides rigid fixation to stabilize vertebrae during spinal fusion surgery. No artificial intelligence or machine learning functions are involved in this device's operation.

Why it mattersWhile not an AI device, this represents the foundational hardware layer upon which some spine surgery guidance systems operate. Surgeons should recognize that this is a passive mechanical implant and distinguish it from any AI-assisted surgical planning or navigation tools that may be used alongside it.

Orthopedic spine surgeons select and implant this hardware intraoperatively during lumbar fusion procedures to achieve mechanical stabilization of the surgical levels.

K Number K253201Product Code KWQCategory Spinal Fixation HardwareReview Panel OrthopedicReceived 09/26/2025
OB/GYNRadiology02/11/2026

Delivery Date AI

Ultrasound AI·FDA De Novo·Biometric Measurement / Gestational Age Estimation

Ultrasound AI's tool automatically estimates gestational age and expected delivery date from fetal ultrasound images. Accurate dating is fundamental to obstetric management  it affects timing of screening tests, interventions, and delivery planning. The AI performs the biometric measurements and calculation automatically from the scan.

Why it mattersAccurate gestational age affects nearly every clinical decision in obstetrics, from when to schedule anatomy scans to how aggressively to manage a preterm birth. Manual biometric measurements vary across sonographers; automated AI measurement with consistent methodology could improve accuracy across high-volume settings. Granted via the De Novo pathway, establishing a new device classification for this AI application.

Directly relevant to OB/GYNs, maternal-fetal medicine specialists, radiologists performing obstetric ultrasounds, and certified nurse midwives. The De Novo pathway means this created a new regulatory classification  expect subsequent 510(k)s from competitors to reference this authorization.

K Number DEN250007Product Code SHECategory Obstetric Ultrasound AI (SaMD)Review Panel RadiologyReceived 03/17/2025
Orthopedics01/28/2026

Sacroiliac Joint Truss System (SJTS)

4Web Medical·FDA 510(k)·Not Applicable  Mechanical Device

This is a wearable sacroiliac joint support brace that provides mechanical stabilization to reduce pain and improve function in patients with sacroiliac joint dysfunction or pain. It is worn externally and helps limit excessive motion at the sacroiliac joint. This device does not use AI or machine learningit is a traditional mechanical orthopedic support.

Why it mattersSacroiliac joint pain and dysfunction affect many patients with lower back pain; a cleared support device offers clinicians a non-invasive option to manage symptoms before escalating to injection or surgical intervention. This reduces reliance on pharmaceutical pain management and provides patients with a low-risk stabilization tool.

Orthopedic surgeons, physiatrists, and physical therapists recommend or prescribe this device during the evaluation and conservative management phase of sacroiliac joint dysfunction, typically after clinical diagnosis and before consideration of more invasive treatments.

K Number K252834Product Code OURCategory Orthopedic Support DeviceReview Panel OrthopedicReceived 09/05/2025
NeurologyRadiology01/22/2026

AI-Rad Companion Brain MR

Siemens Healthcare GmbH·FDA 510(k)·Brain Segmentation / Quantitative Neuroimaging

Siemens' AI-Rad Companion Brain MR automatically segments brain structures from MRI scans and generates quantitative measurements  such as regional brain volumes  that would otherwise require time-intensive manual analysis. It supports neuroradiological assessment of structural brain changes relevant to neurodegeneration, stroke, and other conditions.

Why it mattersQuantitative brain MRI analysis is increasingly clinically relevant as biomarkers for conditions like Alzheimer's disease, multiple sclerosis, and cerebrovascular disease become more actionable. Automated, consistent measurement removes a significant manual bottleneck and enables standardized tracking of changes across serial scans in neurology patients.

Relevant to neuroradiologists, neurologists managing patients with dementia or MS, and clinical researchers. Part of Siemens' AI-Rad Companion ecosystem  meaning it integrates with existing Siemens imaging infrastructure in centers already using that platform.

K Number K253057Product Code QIHCategory Neuroradiology AI / Brain MRI AnalysisReview Panel RadiologyReceived 09/22/2025
OrthopedicsSurgery01/12/2026

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty, Ltd.·FDA 510(k)·3D Reconstruction / Preoperative Planning AI

Precision AI's surgical planning system uses patient CT and X-ray data to generate 3D models and detailed preoperative plans for orthopedic cases. Surgeons can visualize anatomy, plan implant sizing, and simulate surgical approaches before entering the OR. The AI automates bone segmentation and plan generation steps that previously required manual engineering support.

Why it mattersPreoperative 3D planning for arthroplasty and orthopedic reconstruction has been shown to improve implant fit accuracy, reduce intraoperative decision-making burden, and decrease OR time. As AI automates planning, high-quality surgical plans become accessible without requiring specialized imaging engineers  a meaningful workflow shift for orthopedic practices.

Relevant to orthopedic surgeons performing arthroplasty, fracture fixation, and reconstructive procedures. Integrates into preoperative planning from imaging through OR briefing. May reduce reliance on manufacturer-specific planning services tied to proprietary implant systems.

K Number K251558Product Code QHECategory Surgical Planning Software (SaMD)Review Panel OrthopedicReceived 05/21/2025
CardiologyRadiology12/19/2025

AI-CVD

HeartLung Corporation·FDA 510(k)·Disease Detection / Cardiovascular Risk Stratification

HeartLung's AI-CVD analyzes chest CT scans to automatically detect and quantify cardiovascular disease markers  including coronary artery calcium, a strong predictor of future cardiac events. Rather than requiring a dedicated cardiac CT, the AI extracts cardiovascular risk information from chest CTs patients are already having for other reasons.

Why it mattersMillions of chest CTs are performed annually for lung cancer screening, pulmonary embolism, and other indications. Opportunistic AI screening that extracts cardiovascular biomarkers from existing scans  at no additional radiation or cost  could identify high-risk patients who would otherwise receive no preventive cardiology care. Relevant across radiology, cardiology, and primary care.

Relevant to radiologists reading chest CTs, cardiologists receiving referrals for incidental cardiovascular findings, and primary care physicians managing cardiovascular risk. Particularly applicable in lung cancer screening programs where cardiovascular co-morbidity is high.

K Number K252029Product Code QIHCategory Cardiovascular AI / Chest CT AnalysisReview Panel RadiologyReceived 06/30/2025
RadiologySurgeryUltrasound12/17/2025

UltraSight Guidance

Ultrasight , Ltd.·FDA 510(k)·Real-time Image Registration and Needle/Catheter Trajectory Visualization

UltraSight Guidance overlays real-time ultrasound imaging with AI-assisted trajectory visualization to guide interventionalists during needle biopsies, aspirations, and catheter placements. It helps radiologists and surgeons visualize needle paths and target anatomy simultaneously during ultrasound-guided procedures. The system aims to improve procedural accuracy, reduce complications, and shorten procedure time.

Why it mattersUltrasound-guided interventions depend heavily on operator skill and real-time spatial reasoning; this guidance tool can reduce needle redirections, decrease radiation or repeat imaging, and improve safety in complex anatomical cases. It addresses a significant workflow bottleneck in interventional radiology and image-guided surgery where visualization uncertainty can delay procedures or increase patient risk.

Interventional radiologists and surgeons use this software intraoperatively during ultrasound-guided biopsies, aspirations, ablations, and catheter placements to visualize target anatomy and instrument trajectory in real time.

K Number K251416Product Code QJUCategory Image Guidance SoftwareReview Panel RadiologyReceived 05/07/2025
OrthopedicsSurgery12/11/2025

Cervical Spine Truss System - Stand Alone (CSTS-SA)

4Web Medical, Inc.·FDA 510(k)·Not Applicable - Non-AI Device

This is a wearable cervical spine support system designed to stabilize and immobilize the neck in patients with cervical spine injuries or conditions. It functions as a standalone device without requiring external attachment points or infrastructure. The device reduces pain and facilitates healing by limiting harmful motion while maintaining patient mobility and comfort.

Why it mattersThis clearance expands non-surgical treatment options for cervical spine patients, potentially reducing reliance on more restrictive or invasive interventions. Orthopedic surgeons and primary care physicians can now offer patients an FDA-cleared standalone support option that may improve compliance and outcomes in conservative cervical spine management.

Orthopedic surgeons, spine specialists, and primary care physicians prescribe this device during initial evaluation and conservative management of cervical spine conditions, or as part of post-operative immobilization protocols.

K Number K253200Product Code OVECategory Spinal Support/Immobilization DeviceReview Panel OrthopedicReceived 09/26/2025
Neurology12/05/2025

REAL INTELLIGENCE" CORI" XT (CORI XT)

Blue Belt Technologies, Inc.·FDA 510(k)·Intraoperative Image Analysis and Spatial Registration

CORI XT is an AI-assisted surgical navigation system that helps neurosurgeons visualize and track brain and spine anatomy in real time during procedures. It uses computer vision and registration algorithms to align preoperative imaging with the live surgical field, reducing navigation errors. This technology streamlines case setup and improves precision during complex neurosurgical interventions.

Why it mattersSurgical navigation reduces the risk of off-target procedures and collateral damage to critical neural structures, potentially improving patient outcomes and reducing operative time. Adoption of this technology can lower perioperative morbidity and help neurosurgeons manage complex anatomy with greater confidence. This is particularly valuable in minimally invasive spine and brain procedures where direct visualization is limited.

Neurosurgeons and intraoperative neuromonitoring teams integrate CORI XT during the setup and execution phases of brain and spine surgery, from initial case registration through real-time guidance during dissection and target approach.

K Number K252841Product Code OLOCategory Surgical Navigation and Guidance SoftwareReview Panel NeurologyReceived 09/08/2025
Other09/30/2025

TigerConnect Alarm Management

Tigerconnect·FDA 510(k)·Alert Prioritization / Workflow Routing

This is a clinical alarm management and routing platform that processes incoming alerts from medical devices and systems, prioritizes them by severity and clinical context, and directs them to the right clinician at the right time. It reduces alarm fatigue and missed critical notifications by filtering, consolidating, and intelligently distributing alarms across care teams. The system helps prevent delayed responses to patient deterioration and improves communication efficiency in hospital environments.

Why it mattersAlarm fatigue is a major patient safety hazard in hospitalsclinicians are overwhelmed by false and low-priority alerts, leading to missed critical notifications. This system reduces the cognitive burden on staff and ensures that urgent clinical events receive immediate attention, potentially preventing adverse outcomes. Healthcare teams should be aware of this as a tool to reclaim situational awareness and response effectiveness in noisy clinical environments.

Nurses, physicians, and respiratory therapists encounter this system throughout their shifts whenever they receive device alarms (cardiac monitors, ventilators, infusion pumps, etc.), particularly in ICU, acute care, and critical care settings where alert volume is highest.

K Number K243270Product Code MSXCategory Workflow AutomationReview Panel CardiovascularReceived 10/16/2024
Cardiology09/19/2025

Bunkerhill ECG-EF

BunkerHill Health·FDA 510(k)·Pattern Recognition / Diagnostic AI

Bunkerhill ECG-EF uses machine learning to extract cardiac function information directly from standard ECG recordings, enabling rapid assessment of ejection fraction without requiring echocardiography. This tool aids cardiologists and primary care physicians in identifying patients with reduced ejection fraction and potential heart failure. It reduces diagnostic turnaround time and expands screening capacity in resource-limited or point-of-care settings.

Why it mattersEarly identification of reduced ejection fraction is critical for initiating guideline-directed medical therapy and preventing adverse outcomes in heart failure. This AI-driven ECG analysis could democratize access to ejection fraction screening and reduce dependence on echocardiography bottlenecks, particularly in primary care and emergency settings. Clinicians should understand its role as a screening/adjunctive tool rather than a replacement for formal cardiac imaging.

Cardiologists, internists, and emergency medicine physicians use this tool at the point of ECG acquisitionduring routine screening, acute chest pain evaluation, or chronic disease managementto rapidly estimate cardiac function and triage further testing needs.

K Number K250649Product Code QYECategory Diagnostic AIReview Panel CardiovascularReceived 03/04/2025
CardiologyEmergency Medicine09/11/2025

Hypertension Notification Feature (HTNF)

Apple, Inc.·FDA 510(k)·Pattern Recognition / Risk Stratification

Apple's Hypertension Notification Feature analyzes wearable blood pressure data to identify elevated readings and alert users. It is designed for individuals using compatible Apple devices who want passive monitoring of hypertension risk. The feature aims to prompt earlier clinical evaluation and engagement with healthcare providers.

Why it mattersThis clearance establishes an FDA-regulated pathway for consumer wearables to provide clinically meaningful hypertension alerts, potentially enabling earlier detection outside traditional clinical settings. It shifts hypertension screening toward continuous, real-world monitoring rather than episodic office visits. Clinicians should be aware that patients may present with AI-generated hypertension alerts and will need guidance on interpretation and next steps.

Cardiologists, primary care physicians, and emergency clinicians may encounter patients who reference or act on these notifications during routine visits or acute presentations, influencing triage and diagnostic urgency.

K Number K250507Product Code SFRCategory Risk Stratification ToolReview Panel CardiovascularReceived 02/21/2025
CardiologyEmergency MedicineSurgery07/31/2025

BeneVision Central Monitoring System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·FDA 510(k)·Automated Vital Sign Analysis and Alert Generation

This is a central station monitoring platform that aggregates real-time patient vital signs (heart rate, blood pressure, oxygen saturation, etc.) from bedside monitors and applies automated algorithms to detect clinically significant changes. It alerts care teams to potential deterioration across multiple patients simultaneously. It reduces manual vital sign review burden and helps clinicians catch acute changes quickly.

Why it mattersCentral monitoring systems improve response time to patient decompensation in ICUs and high-acuity care units. Automated alerting reduces alarm fatigue and cognitive load on nurses managing multiple patients, while maintaining sensitivity to dangerous arrhythmias and vital sign changes. This directly impacts patient safety and clinician efficiency in critical care.

ICU nurses, cardiac care nurses, and acute care teams use this at the central station throughout their shift to surveil multiple monitored patients and respond to algorithm-generated alerts indicating potential clinical deterioration.

K Number K242728Product Code MSXCategory Patient Monitoring SystemReview Panel CardiovascularReceived 09/10/2024
Cardiology07/28/2025

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

Anumana, Inc.·FDA 510(k)·Pattern Recognition / Risk Stratification

This AI analyzes standard 12-lead ECG recordings to automatically detect patterns associated with low ejection fraction, a marker of heart failure risk. It provides cardiologists and emergency physicians with rapid, objective risk stratification during routine ECG interpretation. The tool helps prioritize patients who may need further cardiac imaging or intervention.

Why it mattersEarly identification of reduced ejection fraction can prompt timely echocardiography and preventive therapies, potentially reducing hospital readmissions and improving outcomes in heart failure. This AI-assisted screening reduces clinician cognitive load and standardizes ECG interpretation across settings. The ability to flag high-risk patients from a simple, ubiquitous test enhances triage efficiency in busy clinical environments.

Cardiologists and emergency medicine physicians encounter this during routine ECG interpretation in outpatient clinics, emergency departments, and acute care settings. The algorithm runs automatically on 12-lead ECG tracings to flag ejection fraction risk before or alongside clinician review.

K Number K250652Product Code QYECategory Diagnostic AIReview Panel CardiovascularReceived 03/04/2025
Cardiology07/15/2025

Tempus ECG-Low EF

Tempus AI, Inc.·FDA 510(k)·Risk Stratification / Predictive Analytics

Tempus ECG-Low EF uses machine learning to analyze ECG waveforms and predict which patients have or are at risk for reduced cardiac ejection fraction. The tool assists cardiologists and primary care clinicians in identifying heart failure candidates who may benefit from further diagnostic testing or preventive therapy. This addresses the challenge of detecting asymptomatic or early-stage systolic dysfunction, which often goes unrecognized until symptoms develop.

Why it mattersEarly identification of reduced EF can prompt timely echocardiography, specialist referral, and initiation of guideline-directed medical therapyinterventions proven to reduce hospitalizations and mortality in heart failure. This AI-assisted approach may reduce diagnostic delays and improve outcomes in asymptomatic patients with structural cardiac dysfunction. The tool extends screening capability beyond traditional clinical suspicion, potentially catching high-risk individuals in routine care settings.

Cardiologists and primary care physicians encounter this tool during initial patient evaluation or routine ECG interpretation, particularly when assessing patients with risk factors for heart failure (hypertension, diabetes, prior MI) or nonspecific symptoms suggestive of cardiac dysfunction.

K Number K250119Product Code QYECategory Risk Stratification ToolReview Panel CardiovascularReceived 01/16/2025
Cardiology06/05/2025

Central Station

Nihon Kohden Digital Health Solutions, LLC·FDA 510(k)·Patient Data Aggregation and Cardiac Signal Processing

The Central Station is a centralized hub for cardiac telemetry that collects and displays real-time heart rhythm and vital sign data from multiple patient monitors in one location. Nurses and cardiologists use it to simultaneously observe multiple patients' cardiac status and receive alerts for critical events. This reduces the need for staff to manually check individual bedside monitors and speeds detection of dangerous arrhythmias.

Why it mattersCentralized cardiac monitoring improves situational awareness for nursing teams managing multiple high-risk patients, enabling faster recognition and response to life-threatening arrhythmias. It reduces alarm fatigue and documentation burden by automating data aggregation. Critical care teams should be aware that this clearance represents FDA's recognition of the device's safety and effectiveness for continuous multi-patient cardiac surveillance.

Cardiac nurses, ICU nurses, and cardiologists use the Central Station throughout shifts in telemetry units, coronary care units, and ICUs to monitor inpatients' real-time heart rhythms and respond to alerts.

K Number K242750Product Code MSXCategory Cardiac Monitoring & Data ManagementReview Panel CardiovascularReceived 09/12/2024
OrthopedicsSurgery04/25/2025

Cervical Spine Truss System (CSTS)

4Web Medical·FDA 510(k)·Not AI/ML-based

The CSTS is a physical cervical spine support system that provides mechanical stabilization to the neck. It is intended for patients with cervical spine conditions requiring external support or immobilization. This is a non-AI orthopedic medical device.

Why it mattersThis device offers orthopedic surgeons and spine specialists a mechanical option for cervical spine stabilization, potentially reducing patient reliance on pharmacological management or invasive procedures. However, this is a special 510(k) clearance for a non-AI device and does not involve algorithmic decision support.

Orthopedic surgeons and spine specialists may prescribe or recommend the CSTS as part of conservative or post-operative management for cervical spine conditions during patient evaluation and treatment planning.

K Number K251117Product Code OVECategory Spinal Support/Stabilization DeviceReview Panel OrthopedicReceived 04/11/2025
RadiologyCardiology04/04/2025

HeartFocus (V.1.1.1)

Deski·FDA 510(k)·Pattern Recognition / Diagnostic AI

HeartFocus uses AI to analyze cardiac imaging (likely echocardiography, CT, or MRI) to help identify heart abnormalities and measure cardiac structures. It is designed for radiologists and cardiologists reviewing patient images. The tool reduces manual measurement time and improves consistency in cardiac assessment.

Why it mattersCardiac imaging interpretation is operator-dependent and time-consuming; standardized AI-assisted analysis can reduce variability and interpretation time. This streamlines workflow in busy imaging departments and cardiology practices, potentially improving turnaround time for urgent cases. Clinicians should be aware this is a decision-support tool requiring physician validation, not an autonomous diagnostic system.

Radiologists and cardiologists use HeartFocus during interpretation of cardiac imaging studies (echocardiograms, cardiac CT, or cardiac MRI) to assist in real-time analysis and measurement before finalizing their clinical report.

K Number K242807Product Code QJUCategory Image Analysis SoftwareReview Panel RadiologyReceived 09/17/2024
CardiologyRadiology01/15/2025

Cardiac Guidance

Caption Health, Inc.·FDA 510(k)·Image Segmentation / Pattern Recognition

Cardiac Guidance uses AI to help clinicians acquire and interpret cardiac ultrasound images in real time, improving image quality and consistency. It assists both experienced sonographers and less-experienced operators by providing guidance during image acquisition and analysis support. The tool reduces variability in echocardiography and helps ensure diagnostic-quality cardiac images are obtained efficiently.

Why it mattersThis device addresses a key challenge in point-of-care and clinical echocardiography: operator-dependent image quality and the shortage of trained cardiac sonographers. By automating guidance during acquisition, Cardiac Guidance can democratize access to high-quality cardiac imaging, reduce scan times, and improve diagnostic confidence across diverse care settings.

Cardiologists, emergency medicine physicians, critical care clinicians, and cardiac sonographers use this tool during real-time echocardiography acquisition and interpretation, particularly in hospital, clinic, and point-of-care settings where rapid cardiac assessment is needed.

K Number K243065Product Code QJUCategory Diagnostic AI / Image Analysis SoftwareReview Panel RadiologyReceived 09/27/2024
Cardiology01/08/2025

ANNE View, Central Hub

Sibel Health, Inc.·FDA 510(k)·Data Integration and Patient Monitoring

ANNE View, Central Hub centralizes cardiovascular patient data and monitoring information in a unified interface for cardiology teams. It aggregates data from multiple sources to support clinical decision-making and patient monitoring workflows. The platform is intended to reduce fragmentation of patient information and streamline access to relevant cardiac data.

Why it mattersCardiologists and cardiac care teams often manage data scattered across multiple systems, increasing cognitive load and decision latency. A centralized hub reduces information silos, supports faster clinical decision-making, and may improve continuity of care in complex cardiac patients. This is particularly relevant in intensive care and high-acuity cardiology settings.

Cardiologists, cardiac intensivists, and cardiac nursing staff use this platform during patient rounds, real-time monitoring, and clinical documentation in inpatient and monitored care settings.

K Number K242842Product Code MSXCategory Workflow Automation / Diagnostic Support SoftwareReview Panel CardiovascularReceived 09/19/2024
Cardiology11/14/2024

Hinscope

Hinlab Sas·FDA 510(k)·Pattern Recognition / Diagnostic AI

Hinscope is a cardiovascular image analysis tool that helps cardiologists and imaging specialists interpret cardiac imaging studies more efficiently. It processes imaging data to identify clinically relevant findings and supports diagnostic assessment. The device is designed to reduce interpretation time and help standardize reporting across different imaging modalities.

Why it mattersCardiovascular imaging interpretation is time-consuming and subject to variability; tools that accelerate analysis and improve consistency can reduce diagnostic delays and improve patient outcomes. Integration of AI-assisted analysis into cardiac imaging workflows can help address radiologist and cardiologist workload while maintaining diagnostic accuracy. This clearance signals FDA validation of the device's safety and effectiveness in the cardiovascular domain.

Cardiologists and cardiac imaging specialists (radiologists, sonographers, and interventionalists) use Hinscope during the image interpretation phase, after acquisition but before clinical reporting and treatment planning decisions.

K Number K241397Product Code MSXCategory Image Analysis SoftwareReview Panel CardiovascularReceived 05/16/2024
Orthopedics11/01/2024

Osteotomy Truss System (OTS)

4Web Medical, Inc.·FDA 510(k)·Surgical planning and osteotomy alignment optimization

The Osteotomy Truss System helps orthopedic surgeons plan and execute bone-cutting procedures with greater precision. It is used during corrective bone surgery to achieve better anatomical alignment and reduce surgical variability. This can improve patient outcomes by reducing malunion and revision surgery rates.

Why it mattersOsteotomy procedures are complex and alignment errors can require costly revision surgery. This system reduces intraoperative decision-making burden and variability, potentially improving first-pass surgical success rates. Orthopedic surgeons should be aware of this tool as a means to standardize and optimize corrective bone surgery outcomes.

Orthopedic surgeons performing corrective osteotomy procedures encounter this system during surgical planning and intraoperative guidance phases of bone realignment surgeries.

K Number K240388Product Code HRSCategory Surgical Planning & Guidance SystemReview Panel OrthopedicReceived 02/08/2024
RadiologyEmergency MedicineNeurology09/24/2024

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.·FDA 510(k)·Pattern Recognition / Image Analysis

This AI analyzes head CT scans to rapidly identify and characterize intracranial bleeding, helping emergency and radiology teams quickly triage patients with potential stroke or traumatic brain injury. It flags suspected ICH regions and provides supporting measurements, reducing time-to-diagnosis in high-stakes neuroimaging scenarios. The tool is designed for use in emergency departments and imaging centers where rapid hemorrhage detection directly impacts patient outcomes.

Why it mattersIntracranial hemorrhage requires immediate intervention, and delays in detection increase risk of poor neurological outcomes. This AI accelerates the critical first step of hemorrhage identification and characterization, potentially reducing interpretation time during off-hours or in resource-constrained settings. Clinicians should recognize this as a real-time decision-support tool that complements rather than replaces expert radiologist review.

Emergency radiologists and on-call physicians encounter this tool immediately after a patient with suspected acute head injury or stroke arrives, when rapid CT triage is essential to guide immediate clinical management decisions.

K Number K242292Product Code QASCategory Computer-Aided Detection (CAD)Review Panel RadiologyReceived 08/02/2024
Radiology09/06/2024

uAI Portal

Shanghai United Imaging Intelligence Co., Ltd.·FDA 510(k)·Pattern Recognition / Diagnostic AI

The uAI Portal is an AI-assisted image analysis platform that helps radiologists interpret medical images more efficiently and consistently. It applies machine learning algorithms to detect patterns and potential abnormalities in radiological studies. The tool is intended to streamline radiology workflows and support clinical decision-making in diagnostic imaging.

Why it mattersThis clearance expands the toolkit available to radiology departments for improving diagnostic accuracy and throughput in busy imaging centers. AI-assisted image analysis can help reduce interpretation variability and flag findings that might warrant closer attention, particularly valuable in high-volume settings. Radiologists should understand this as a decision-support tool that augmentsnot replacesexpert interpretation.

Radiologists integrate this tool into their daily image interpretation workflow, typically during the primary review phase of CT, MRI, X-ray, or other modality studies to assist with detection and characterization tasks.

K Number K240411Product Code QIHCategory Image Analysis SoftwareReview Panel RadiologyReceived 02/12/2024
Radiology08/08/2024

SynthVISION 1.0.0

Synthesis Health Intelligence, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

SynthVISION is an AI image analysis tool that helps radiologists identify and characterize findings in medical images. It processes imaging data to detect patterns consistent with pathology, supporting diagnostic decision-making. The software is designed to enhance radiologist efficiency and consistency in image interpretation.

Why it mattersThis AI-assisted tool can reduce interpretation time and variability in radiologic reporting, potentially improving diagnostic accuracy and throughput in busy imaging departments. Radiologists should understand its capabilities and limitations to appropriately integrate it into their workflow and maintain clinical oversight.

Radiologists use this tool during image review and interpretation, after image acquisition and before finalizing diagnostic reports. It serves as a decision-support aid that highlights regions of interest or suspected abnormalities for radiologist confirmation.

K Number K240724Product Code LLZCategory Image Analysis SoftwareReview Panel RadiologyReceived 03/18/2024
Gastroenterology07/25/2024

GI Genius" Module 100 (GGM100.US); GI Genius" Module 200 (GGM200.US); ColonPRO" 4.0 (CPRO40.US); GI Genius" Module 300 (GGM300-US); ColonPRO" 4.0 (CPRO40S-US)

Cosmo Artificial Intelligence - Ai, Ltd.·FDA 510(k)·Pattern Recognition / Diagnostic AI

GI Genius and ColonPRO are AI systems that analyze video during live colonoscopy to help gastroenterologists detect polyps and lesions in real time. The software flags potential abnormalities on the endoscopy monitor as the procedure unfolds. This addresses the clinical challenge of polyp miss rates during screening colonoscopies, which can compromise cancer prevention.

Why it mattersPolyp miss rates remain a significant quality metric in colonoscopy and a driver of interval colorectal cancers. AI-assisted detection can reduce operator-dependent variability and improve adenoma detection rates, directly impacting screening effectiveness and patient outcomes. Gastroenterologists should be aware this technology is now cleared to augment their real-time diagnostic capability during routine procedures.

Gastroenterologists use this during colonoscopy screening and surveillance procedures; the AI operates passively on the endoscopy video stream and alerts the endoscopist to potential polyps in real time for clinical decision-making.

K Number K241887Product Code QNPCategory Computer-Aided Detection (CAD)Review Panel Gastroenterology, UrologyReceived 06/28/2024
CardiologySurgeryEmergency Medicine07/12/2024

Infinity Gateway Suite

Draeger Medical Systems, Inc.·FDA 510(k)·Real-time Data Integration and Clinical Alerting

The Infinity Gateway Suite aggregates vital signs, hemodynamic parameters, and device data into a unified platform for cardiac and surgical teams. It enables real-time visibility of patient status across multiple monitoring sources, reducing fragmentation and supporting faster clinical decision-making. The system is designed for ICU, OR, and cardiac care settings where continuous multimodal data fusion is critical.

Why it mattersIntegrated monitoring platforms reduce alarm fatigue, improve data accessibility, and lower the cognitive load on clinicians managing complex cardiac and post-operative patients. This can decrease response times to deterioration and support standardized escalation protocols. HCPs should understand this as infrastructure that improves situation awareness rather than replacing clinical judgment.

Cardiac intensivists, operating room teams, and cardiac surgeons use this platform throughout patient monitoring phasesfrom ICU admission through dischargeto consolidate real-time waveforms, numerics, and derived parameters in one interface.

K Number K233834Product Code MSXCategory Clinical Decision Support / Workflow Integration PlatformReview Panel CardiovascularReceived 12/04/2023
Other07/02/2024

Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)

Shenzhen Micro Electric Intelligence Co., Ltd.·FDA 510(k)·Not AI/ML Device

This is a traditional ultrasonic scaling device used by dental hygienists and dentists to remove hardened calculus and plaque buildup from teeth. It is not an AI or machine learning deviceit is a standard electromechanical instrument that vibrates at ultrasonic frequencies to perform mechanical cleaning. It addresses the routine clinical need for efficient plaque and calculus removal during preventive dental care.

Why it mattersThis device is a conventional dental instrument with no AI/ML component and should not be tracked as part of an AI/ML device intelligence platform. It represents traditional dental hygiene equipment cleared through standard 510(k) pathway. Clinicians should note this is a mechanical tool, not an intelligent or algorithmic system.

Dental hygienists and general dentists use this during routine prophylaxis and periodontal maintenance appointments as part of standard plaque and calculus removal protocols.

K Number K240707Product Code ELCCategory Dental Hygiene EquipmentReview Panel DentalReceived 03/15/2024
Cardiology06/21/2024

Tempus ECG-AF

Tempus AI, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

Tempus ECG-AF uses machine learning to analyze 12-lead ECG recordings and identify patterns associated with atrial fibrillation (AF), helping cardiologists and primary care clinicians flag patients at risk or with subclinical AF. The tool processes standard ECG data without requiring additional hardware or patient testing. It reduces the cognitive burden of manual ECG review and may help identify AF earlier in asymptomatic or paroxysmal presentations.

Why it mattersEarly detection of atrial fibrillation is critical for stroke prevention and management, yet AF is frequently missed on routine ECGs, especially paroxysmal episodes. This AI can augment clinician review and standardize interpretation across settings. The technology extends AF screening capability beyond specialized cardiology centers to primary care and emergency settings where ECGs are routinely performed.

Cardiologists and primary care physicians encounter this tool during ECG interpretationboth in acute care settings (chest pain evaluation, syncope workup) and routine screening (annual physicals, pre-operative clearance). It functions as a second-reader to flag high-risk tracings for further investigation or specialist referral.

K Number K233549Product Code SBQCategory Diagnostic AIReview Panel CardiovascularReceived 11/03/2023
Other05/31/2024

Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)

Anhui Miisen Intelligence Technology Co., Ltd.·FDA 510(k)·Not Applicable  Material Science / Manufacturing

This is a zirconia ceramic material block used in computer-aided design and computer-aided manufacturing (CAD/CAM) dental milling systems to fabricate custom crowns and bridges. Dentists mill these blocks into patient-specific restorations. No AI or machine learning component is involved; this is a passive prosthetic material.

Why it mattersZirconia is a high-strength, esthetic dental ceramic widely used in modern prosthodontics. This clearance confirms biocompatibility and mechanical performance for tooth restoration. Clinicians should note this is a material substrate, not an intelligent software tool.

Prosthodontists and general dentists using CAD/CAM milling systems select zirconia blocks during digital restoration design and fabrication in the laboratory or chairside milling setting.

K Number K240912Product Code EIHCategory Dental Material / Zirconia Prosthetic BlockReview Panel DentalReceived 04/03/2024
Cardiology05/09/2024

Biofourmis Everion+ (G2)

Biofourmis Singapore Pte., Ltd.·FDA 510(k)·Continuous Vital Sign Analysis and Cardiovascular Risk Detection

Everion+ (G2) is a wearable patch that continuously monitors heart rhythm, heart rate, respiratory rate, and other vital signs, using AI to identify patterns indicative of cardiac risk or deterioration. It is intended for patients at risk of or with known cardiovascular disease who require remote monitoring. The device reduces the need for frequent clinical visits and alerts providers to potential cardiac events before symptomatic presentation.

Why it mattersThis device extends cardiac monitoring beyond episodic ECGs or Holter monitors into truly continuous surveillance, enabling earlier detection of arrhythmias and hemodynamic changes. It shifts the burden of monitoring from the clinic to the patient's home, improving adherence and enabling faster intervention. Clinicians gain actionable alerts rather than raw data, supporting proactive rather than reactive cardiology.

Cardiologists and primary care providers managing patients with atrial fibrillation, heart failure, post-MI recovery, or arrhythmia risk use this device as part of remote patient monitoring programs, typically initiating it during a routine office visit or hospitalization and reviewing alerts and summary reports during follow-up.

K Number K233418Product Code MSXCategory Wearable Monitoring & Risk StratificationReview Panel CardiovascularReceived 10/10/2023
OrthopedicsSurgery04/22/2024

Anterior Spine Truss System-Stand Alone (ASTS-SA)

4Web Medical, Inc.·FDA 510(k)·N/A  Device Class

This is a standalone anterior spine implant designed to stabilize and fuse vertebrae in the neck or upper back without requiring supplemental posterior fixation. It is used by spine surgeons during anterior cervical or thoracic fusion procedures to support bone healing and restore spinal alignment. The device reduces the need for additional hardware and revision surgeries by offering a complete solution for anterior column reconstruction.

Why it mattersStand-alone anterior fusion systems simplify surgical technique, reduce operative time, and lower morbidity compared to hybrid approaches requiring both anterior and posterior instrumentation. This clearance expands treatment options for patients with degenerative disc disease, trauma, or deformity, potentially improving fusion rates and patient recovery. Spine surgeons should be aware of this option when planning anterior cervical or thoracic reconstructive procedures.

Spine surgeons and surgical teams evaluate this device during preoperative planning and implant selection for patients scheduled for anterior cervical or thoracic fusion, typically in the OR setting.

K Number K233966Product Code OVDCategory Spinal Implant SystemReview Panel OrthopedicReceived 12/15/2023
Cardiology04/05/2024

CorVista System with PH Add-On

Analytics For Life, Inc.·FDA 510(k)·Pattern Recognition / Risk Stratification

CorVista is a diagnostic AI system that analyzes hemodynamic measurements to help cardiologists assess cardiac function and pulmonary pressure status. It processes physiologic data to stratify patient risk and guide therapeutic decisions. The system reduces manual interpretation burden and standardizes hemodynamic assessment across care settings.

Why it mattersHemodynamic assessment is critical for managing heart failure and pulmonary hypertension, but interpretation is time-consuming and subject to variability. This tool standardizes analysis and can accelerate clinical decision-making in acute and chronic care settings. Clinicians should be aware that this device supportsbut does not replaceclinical judgment in hemodynamic management.

Cardiologists and intensivists use this system when evaluating patients with suspected or known heart failure or pulmonary hypertension, particularly during invasive hemodynamic monitoring or when analyzing non-invasive hemodynamic surrogates.

K Number K233666Product Code SATCategory Diagnostic AIReview Panel CardiovascularReceived 11/15/2023
Cardiology03/28/2024

Eko Low Ejection Fraction Tool (ELEFT)

Eko Health, Inc.·FDA 510(k)·Pattern Recognition / Automated Measurement

Eko ELEFT is an AI tool that analyzes cardiac ultrasound images to detect and measure low ejection fractiona key indicator of heart failure. It processes echocardiogram data to provide automated quantification, helping cardiologists and emergency physicians quickly identify patients at risk. This reduces manual measurement time and improves consistency in a critical screening assessment.

Why it mattersEjection fraction assessment is central to heart failure diagnosis and risk stratification, but manual measurement is time-consuming and operator-dependent. Automated AI detection accelerates identification of hemodynamically significant dysfunction and standardizes measurement across settings. This is particularly valuable in high-volume or resource-constrained environments where rapid, accurate EF assessment directly impacts triage and treatment decisions.

Cardiologists and emergency medicine physicians use this during or immediately after echocardiography acquisition to obtain rapid, reproducible ejection fraction estimates and flagging of reduced function cases.

K Number K233409Product Code QYECategory Diagnostic AI / Risk Stratification ToolReview Panel CardiovascularReceived 10/06/2023
Cardiology03/22/2024

Corsano CardioWatch 287-2 System

Corsano Health B.V.·FDA 510(k)·Pattern Recognition / Diagnostic AI

This is a wearable cardiac monitor that continuously tracks heart rhythm and uses pattern recognition to identify abnormal cardiac events. It's designed for patients who need extended heart monitoring outside the clinic or hospital setting. The system helps detect paroxysmal arrhythmias and other cardiac conditions that may be missed during brief office visits or standard ECGs.

Why it mattersWearable cardiac monitors extend diagnostic capability beyond episodic clinic encounters, enabling detection of intermittent arrhythmias that carry clinical risk. This reduces the need for repeated office visits or prolonged inpatient monitoring while improving diagnostic yield. Clinicians can now access continuous cardiac data to inform treatment decisions and patient management strategies.

Cardiologists and primary care clinicians order this device for patients with palpitations, syncope, or known arrhythmia risk; the monitor operates continuously in the outpatient setting and alerts clinicians to significant events detected via AI pattern analysis.

K Number K232548Product Code MSXCategory Wearable Cardiac Monitoring SystemReview Panel CardiovascularReceived 08/23/2023
Orthopedics03/21/2024

Ankle Truss System (ATS)

4Web Medical, Inc.·FDA 510(k)·Not applicable  mechanical device

The Ankle Truss System is a wearable ankle brace designed to stabilize and support the ankle joint during recovery from injury or management of chronic ankle instability. It is used by patients with ankle sprains, fractures, or chronic ankle weakness to reduce pain and improve functional mobility. This device reduces reliance on more restrictive immobilization methods while maintaining joint stability.

Why it mattersThis device offers orthopedic patients a less restrictive alternative to traditional ankle bracing or casting, potentially improving mobility and quality of life during recovery. Clinicians can recommend this device for early mobilization protocols that may reduce complications associated with prolonged immobilization. Its approval expands non-invasive treatment options for common ankle injuries in primary care and sports medicine settings.

Orthopedic surgeons, sports medicine physicians, and primary care clinicians recommend this device to patients during the acute and subacute phases of ankle injury management, typically following initial evaluation and imaging confirmation of injury severity.

K Number K230088Product Code SAICategory Orthopedic Support DeviceReview Panel OrthopedicReceived 01/12/2023
Neurology03/18/2024

Real Intelligence" CORI"

Blue Belt Technologies, Inc.·FDA 510(k)·Pattern Recognition / Image Segmentation

Real Intelligence CORI uses machine learning to analyze neurological imaging data and identify patterns that may aid clinical interpretation. The software is intended for use by neurologists and neuroradiologists reviewing brain or spinal imaging studies. It helps reduce interpretation time and provides a secondary analysis layer to support diagnostic accuracy.

Why it mattersThis clearance enables broader adoption of AI-assisted interpretation in neurology practices, potentially reducing diagnostic turnaround times and improving consistency in complex imaging review. As neurological conditions often require rapid diagnosis, automation of preliminary image analysis can accelerate clinical decision-making and reduce clinician cognitive load.

Neurologists and neuroradiologists use this tool during imaging review and interpretation workflows, typically after acquisition of MRI, CT, or other neurological imaging studies and before final clinical report generation.

K Number K240139Product Code OLOCategory Image Analysis SoftwareReview Panel NeurologyReceived 01/18/2024
PathologyOB/GYN01/31/2024

Genius" Digital Diagnostics System with the Genius" Cervical AI algorithm

Hologic, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

This AI system analyzes digital images of cervical cell samples to help pathologists identify abnormal cells and potential precancerous changes. It's designed for use in cytopathology labs processing cervical cancer screening samples. The algorithm flags areas of concern and provides decision support to improve detection accuracy and laboratory efficiency.

Why it mattersCervical cancer screening relies on accurate cytology interpretation, and AI-assisted detection can reduce missed abnormalities and improve consistency across laboratories. This reduces diagnostic errors and supports pathologists managing high-volume screening workloads. Implementation streamlines triage and reporting workflows in anatomic pathology practices.

Pathologists and cytotechnologists use this system during primary or secondary review of cervical cytology slides in hospital and reference laboratories, typically after specimen preparation and slide digitization.

K Number DEN210035Product Code QYVCategory Computer-Aided Detection (CAD)Review Panel PathologyReceived 08/27/2021
Gastroenterology01/12/2024

GI Genius" Module 100 (GGM100.US); GI Genius" Module 200 (GGM200.US); ColonPRO" 4.0 (CPRO40.US)

Cosmo Artificial Intelligence - Ai, Ltd.·FDA 510(k)·Pattern Recognition / Diagnostic AI

This AI-powered system analyzes live colonoscopy video to automatically detect and highlight polyps on the endoscope screen in real-time. It's designed for gastroenterologists performing screening or surveillance colonoscopies to help ensure no polyps are missed. By flagging lesions as they're encountered, it reduces the miss rate of precancerous and cancerous polyps.

Why it mattersMissed polyps during colonoscopy are a leading cause of interval colorectal cancers. This real-time detection aid directly addresses adenoma miss ratea critical quality metric in endoscopyand could improve screening effectiveness at scale. Clinicians should be aware this represents an FDA-cleared workflow augmentation tool validated for polyp detection.

Gastroenterologists using compatible colonoscopy platforms encounter this tool during the procedural phase, as the AI processes live video feed and provides visual alerts to guide tissue inspection and biopsy decisions.

K Number K233964Product Code QNPCategory Computer-Aided Detection (CAD)Review Panel Gastroenterology, UrologyReceived 12/15/2023
Cardiology09/28/2023

Low Ejection Fraction AI-ECG Algorithm

Anumana, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

This AI algorithm analyzes standard ECG readings to detect patients at risk for reduced heart pumping function (low ejection fraction) without requiring echocardiography. It provides cardiologists and primary care physicians with an automated risk flag from a widely available, inexpensive test. This addresses the clinical gap of identifying asymptomatic patients who may benefit from further cardiac evaluation or preventive therapy.

Why it mattersEarly identification of low ejection fraction reduces heart failure progression, hospital admissions, and mortality through timely intervention. This AI enables screening in resource-limited settings and primary care where echocardiography access is limited. The algorithm transforms the ECGalready routine in clinical practiceinto a functional cardiac screening tool.

Cardiologists and primary care physicians encounter this tool during ECG interpretation, particularly in screening populations, post-MI follow-up, or patients with risk factors for heart failure. The AI provides decision support at the point of ECG reading.

K Number K232699Product Code QYECategory Risk Stratification ToolReview Panel CardiovascularReceived 09/05/2023
Radiology09/14/2023

OrionXR

Hoth Intelligence, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

OrionXR uses machine learning to analyze medical images and highlight potential abnormalities, helping radiologists prioritize cases and reduce interpretation time. The software is designed for radiologists reviewing diagnostic imaging studies in clinical settings. It aims to improve diagnostic accuracy and workflow efficiency by providing computer-aided analysis of radiographic findings.

Why it mattersThis AI tool can reduce radiologist cognitive burden and interpretation time while potentially improving detection consistency, particularly for high-volume imaging practices. As imaging volumes continue to grow, AI-assisted analysis helps maintain diagnostic quality without proportional increases in staffing. Radiologists should be aware of this as a validated decision-support tool that augments but does not replace expert interpretation.

Radiologists use OrionXR during the primary interpretation phase of diagnostic imaging studies, either as a real-time second reader or as a retrospective quality assurance check on their own interpretations.

K Number K232189Product Code LLZCategory Image Analysis SoftwareReview Panel RadiologyReceived 07/24/2023
Radiology09/08/2023

DeepXray

Alpha Intelligence Manifolds, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

DeepXray uses deep learning to analyze chest X-ray images and highlight potential abnormalities for radiologist review. It serves as a second reader tool to improve detection sensitivity and reduce diagnostic errors. The software processes standard radiographic images and provides localized alerts on regions of concern.

Why it mattersThis AI tool addresses the challenge of missed or delayed diagnoses on chest imaging, which remains a leading source of diagnostic error in radiology. By providing automated flagging of suspicious regions, DeepXray can help reduce radiologist fatigue, improve throughput in high-volume settings, and catch subtle findings that might otherwise be overlooked. Its deployment could standardize diagnostic quality across institutions with varying radiologist expertise.

Radiologists and technicians encounter this tool during the interpretation phase of chest X-ray studies, either as a concurrent or retrospective review aid. It integrates into the typical radiology PACS workflow to expedite reporting and quality assurance.

K Number K223621Product Code QIHCategory Computer-Aided Detection (CAD)Review Panel RadiologyReceived 12/05/2022
Cardiology09/08/2023

CorVista® System

Corvista Health, Inc.·FDA 510(k)·Pattern Recognition / Predictive Analytics

CorVista® is an AI-powered diagnostic system that analyzes cardiac patient data to identify risk patterns and support clinical decision-making in cardiovascular disease assessment. It targets cardiologists and cardiovascular specialists managing patients with suspected or known heart disease. The system helps reduce diagnostic uncertainty and standardizes risk assessment across diverse patient populations.

Why it mattersThis tool streamlines cardiovascular risk evaluation by automating complex pattern analysis, potentially reducing time to diagnosis and improving consistency of care. It addresses the clinical challenge of rapidly stratifying cardiac patients into appropriate risk tiers, which directly impacts treatment urgency and resource allocation. Clinicians should be aware of it as a decision-support adjunct that can enhance accuracy in high-stakes cardiac risk assessment.

Cardiologists and cardiovascular specialists use this system during initial patient evaluation or risk assessment phases, either in acute care, outpatient, or pre-intervention settings to inform treatment strategy decisions.

K Number K232686Product Code QXXCategory Diagnostic AI / Risk Stratification ToolReview Panel CardiovascularReceived 09/01/2023
Cardiology08/03/2023

Viz HCM

Viz. Ai, Inc.·FDA 510(k)·Pattern Recognition / Image Analysis

Viz HCM uses AI to identify and characterize features of hypertrophic cardiomyopathy on cardiac images. The software assists cardiologists in evaluating patients suspected of having HCM, potentially reducing diagnostic interpretation time and supporting clinical decision-making. It targets cardiology practices and hospital imaging centers where HCM assessment is performed.

Why it mattersHCM is a leading cause of sudden cardiac death in young people and a common reason for cardiology referral; faster, more consistent AI-assisted detection supports earlier risk stratification and appropriate patient management. This direct 510(k) clearance reflects FDA confidence in the technology's safety and effectiveness, enabling broader clinical adoption. Cardiologists can now incorporate AI-assisted HCM analysis into routine imaging workflows.

Cardiologists and cardiac imaging specialists use Viz HCM during the image interpretation phase when reviewing echocardiography, cardiac MRI, or CT studies in patients with suspected or known HCM.

K Number DEN230003Product Code QXOCategory Diagnostic AIReview Panel CardiovascularReceived 01/10/2023
Neurology08/01/2023

REAL INTELLIGENCE" CORI"

Blue Belt Technologies, Inc.·FDA 510(k)·Pattern Recognition / Diagnostic AI

REAL INTELLIGENCE CORI is an AI system designed to help neurologists analyze neurological imaging or patient data more efficiently. It uses machine learning to identify patterns that may indicate neurological conditions, serving as a second reader or decision support tool. This device aims to reduce diagnostic variability and improve the speed of neurological assessment.

Why it mattersThis device represents an advance in neurological diagnostics by bringing AI-assisted analysis to neurology workflows, potentially reducing time to diagnosis and improving consistency across clinicians. It may decrease cognitive burden on neurologists reviewing complex imaging or data, particularly in high-volume settings. Early adoption awareness is important as neurology practices evaluate how to integrate AI decision support into clinical workflows.

Neurologists use this tool during the diagnostic phase when reviewing imaging studies (MRI, CT) or analyzing clinical neurological data to inform differential diagnosis and treatment planning decisions.

K Number K231963Product Code OLOCategory Diagnostic AIReview Panel NeurologyReceived 07/03/2023
Radiology07/24/2023

UltraSight AI Guidance

Ultrasight, Inc.·FDA 510(k)·Real-time Image Analysis and Guidance

UltraSight AI Guidance uses machine learning to analyze live ultrasound images and provide real-time procedural guidance during needle or catheter placement. It assists radiologists and interventionalists in identifying anatomical landmarks and optimizing device trajectory during image-guided procedures. The tool aims to improve procedure success rates and reduce complications from needle misplacement.

Why it mattersImproved guidance during ultrasound procedures can reduce procedure time, lower complication rates, and increase success on first attemptparticularly valuable in challenging anatomy or operator-dependent procedures. This represents a shift toward AI-augmented rather than AI-independent decision-making in interventional practice. Clinicians should understand its role as a guidance aid that requires procedural expertise and clinical judgment.

Radiologists and interventionalists use this tool in real time during ultrasound-guided biopsies, aspirations, injections, and vascular access procedures, integrated directly into their imaging workflow.

K Number K223347Product Code QJUCategory Image-Guided Intervention SoftwareReview Panel RadiologyReceived 11/01/2022
Gastroenterology05/19/2023

GI Genius System 100 and GI Genius System 200

Cosmo Artificial Intelligence - Ai, Ltd.·FDA 510(k)·Pattern Recognition / Diagnostic AI

GI Genius is an AI-powered system that analyzes live video during colonoscopy to identify and highlight polyps in real time, helping gastroenterologists detect lesions they might otherwise miss. It is used during routine colonoscopy screening and surveillance procedures. This technology reduces polyp miss rates and improves detection sensitivity during endoscopic procedures.

Why it mattersPolyp detection rates vary significantly between endoscopists, and missed polyps are a known cause of interval colorectal cancers. By providing real-time AI-assisted detection, GI Genius can standardize quality and reduce clinically significant miss rates, improving patient outcomes and reducing downstream cancer risk. This represents a shift toward augmented intelligence in endoscopy.

Gastroenterologists and endoscopy technicians use this system during colonoscopy proceduresthe AI analyzes the endoscopic video stream in real time and alerts the clinician to suspicious lesions during the procedure itself.

K Number K231143Product Code QNPCategory Computer-Aided Detection (CAD)Review Panel Gastroenterology, UrologyReceived 04/21/2023
Radiology04/20/2023

Deep Learning Image Reconstruction

Ge Healthcare Japan Corporation·FDA 510(k)·Image Reconstruction / Pattern Recognition

This GE Healthcare AI tool uses deep learning to reconstruct medical images from raw scanner data, producing clearer, higher-quality diagnostic images. It applies across multiple imaging modalities and works within existing radiology workflows. The system enhances image clarity while maintaining diagnostic accuracy.

Why it mattersImage reconstruction AI can reduce noise and artifacts, lower radiation or contrast doses, and accelerate image processingdirectly improving both diagnostic confidence and patient safety. Radiologists should understand that this reconstructed output maintains FDA clearance standards and can integrate seamlessly into PACS and reporting systems.

Radiologists and imaging technicians encounter this tool immediately after image acquisition, during the reconstruction and preprocessing phase, before diagnostic interpretation and reporting.

K Number K230807Product Code JAKCategory Image Analysis SoftwareReview Panel RadiologyReceived 03/23/2023
CardiologyRadiology02/24/2023

Caption Interpretation Automated Ejection Fraction Software

Caption Health, Inc.·FDA 510(k)·Automated Measurement / Image Segmentation

Caption's software uses AI to automatically measure ejection fractiona key indicator of heart pump functionfrom ultrasound images. It is intended for use by sonographers and cardiologists performing echocardiograms. This reduces the time and subjectivity involved in manual LVEF measurement and improves consistency of cardiac assessments.

Why it mattersEjection fraction is critical for diagnosing heart failure and guiding treatment, but manual measurement is time-consuming and operator-dependent. Automated, consistent LVEF quantification can accelerate reporting, reduce measurement variability, and improve clinical decision-making in high-volume echo labs and point-of-care settings.

Sonographers and cardiologists use this during or immediately after echocardiogram acquisition to obtain rapid, standardized LVEF measurements for real-time clinical decision-making and formal report generation.

K Number DEN220063Product Code QVDCategory Image Analysis SoftwareReview Panel RadiologyReceived 09/28/2022
Radiology02/16/2023

uMR 680

Shanghai United Imaging Intelligence Co., Ltd.·FDA 510(k)·Image Acquisition and Reconstruction

The uMR 680 is an MRI scanner that acquires and processes magnetic resonance images of patients for diagnostic purposes. It is used by radiologists and other clinicians who need detailed cross-sectional imaging of organs, tissues, and structures. The device enables visualization of anatomy and pathology without ionizing radiation.

Why it mattersMRI is a cornerstone diagnostic modality that avoids radiation exposure while providing high-resolution soft tissue contrast. Expanding access to capable MRI systems improves diagnostic capabilities and efficiency in radiology departments. Clinicians benefit from modern imaging technology that supports faster acquisitions and higher image quality.

Radiologists and imaging technologists use this device during the diagnostic imaging phase of patient workups, from routine screening and problem-solving to pre-operative planning and follow-up surveillance across nearly all clinical specialties.

K Number K222755Product Code LNHCategory MRI SystemReview Panel RadiologyReceived 09/12/2022

Key Takeaways

  • 81 FDA-cleared AI/ML medical devices tracked across 7 specialties
  • Each device has a plain-English “Why it matters” summary framing its clinical impact
  • Filter by specialty — cardiology, radiology, neurology, oncology, OB/GYN, orthopedics, pulmonology
  • Each entry links to the official FDA record with K-number, product code, category, and review panel
  • Data drawn from FDA 510(k) and De Novo clearances, refreshed automatically

Frequently Asked Questions

What is the FDA AI/ML medical device tracker?

A continuously updated list of FDA-cleared AI/ML-enabled medical devices, organized by specialty, with plain-English summaries of what each device does and why it matters clinically.

Where does the data come from?

Entries are compiled from FDA 510(k) and De Novo clearance records. Each entry links to the official FDA record with K-number, product code, category, and review panel.

How often is it updated?

The tracker is refreshed automatically as new AI/ML-enabled devices clear the FDA via OpenFDA.

What counts as an "AI/ML-enabled" device?

Devices that use artificial intelligence or machine learning as part of their cleared function — such as detection, diagnosis, triage, or measurement support — as reflected in their FDA clearance.

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