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FDA-listed AI/ML-enabled medical devices

Devices the FDA identifies as using artificial intelligence or machine learning, with the regulators each one is registered with.

1,255 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
ClearRead CT CAC

Riverain Technologies

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
ClearRead Xray Pneumothorax

Riverain Technologies

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
ClearView cCAD

Clearview Diagnostics, Inc.

Registered with
  • US (FDA)
Cleerly ISCHEMIA

Cleerly, Inc.

Registered with
  • US (FDA)
Cleerly Labs

Cleerly, Inc.

Registered with
  • US (FDA)
Cleerly Labs v2.0

Cleerly, Inc.

Registered with
  • US (FDA)
Clever One

Ewoosoft Co., Ltd.

Registered with
  • US (FDA)
CLEWICU System

Clew Medical , Ltd.

Registered with
  • US (FDA)
CLEWICU System (ClewICUServer and ClewICUnitor)

Clew Medical , Ltd.

Registered with
  • US (FDA)
cmAngio® V1.0

Curemetrix, Inc.

Registered with
  • US (FDA)
cmAngio® (V1.6)

Curemetrix, Inc.

Registered with
  • US (FDA)
cmTriage

Curemetrix, Inc.

Registered with
  • US (FDA)
cNeuro cMRI

Combinostics Oy

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Co-Ablation System with Sterile Co-Ablation Probe

Hygea Medical Technology Co, Ltd

Registered with
  • US (FDA)
CogNet AI-MT+

Medcognetics, Inc.

Registered with
  • US (FDA)
CogNet QmTRIAGE

Medcognetics, Inc.

Registered with
  • US (FDA)
Cognoa ASD Diagnosis Aid

Cognoa, Inc.

Registered with
  • US (FDA)
CoLumbo

Smart Soft Healthcare AD

Registered with
  • US (FDA)
  • EU (EUDAMED)
CoLumboX

Smart Soft Healthcare AD

Registered with
  • US (FDA)
Complete Control System Gen2

Coapt, LLC

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Constellation (CON-001)

Q Bio, Inc.

Registered with
  • US (FDA)
ContaCT

Viz.Al, Inc.

Registered with
  • US (FDA)
Contour+ (MVision AI Segmentation)

Mvision AI OY

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Contour ProtegeAI

Mim Software, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Contour ProtégéAI+

Mim Software, Inc.

Registered with
  • US (FDA)
CorInsights MRI

Adm Diagnostics, Inc.

Registered with
  • US (FDA)
Corvair

AliveCor, Inc.

Registered with
  • US (FDA)
  • AU (TGA)
Corvair Monza

AliveCor, Inc.

Registered with
  • US (FDA)
CorVista® System

Corvista Health, Inc.

Registered with
  • US (FDA)
CorVista System with PH Add-On

Analytics For Life, Inc.

Registered with
  • US (FDA)
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Brainlab SE

Registered with
  • US (FDA)
Critical Care Suite

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Critical Care Suite with Endotracheal Tube Positing AI algorithm

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

Omega Medical Imaging, Inc.

Registered with
  • US (FDA)
CT 5300

Philips Healthcare (Suzhou) Co., Ltd.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
CT Cardiomegaly

Innolitics, LLC

Registered with
  • US (FDA)
CT CoPilot

Zepmed, LLC

Registered with
  • US (FDA)
CT Rembra RT; CT Areta RT; CT Rembra

Philips Healthcare (Suzhou) Co., Ltd.

Registered with
  • US (FDA)
CT VScore+

Canon Medical Informatics Inc

Registered with
  • US (FDA)
CuraRad-ICH

Curacloud Corp.

Registered with
  • US (FDA)
Customize

3D-Side S.A.

Registered with
  • US (FDA)
  • AU (TGA)
cvi42

Circle Cardiovascular Imaging, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
cvi42 Auto Imaging Software Application

Circle Cardiovascular Imaging, Inc.

Registered with
  • US (FDA)
cvi42 Coronary Plaque Software Application

Circle Cardiovascular Imaging, Inc.

Registered with
  • US (FDA)
cvi42 Software Application

Circle Cardiovascular Imaging, Inc.

Registered with
  • US (FDA)
Cydar EV

Cydar , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Cydar EV (Series B) and Cydar EV Maps

Cydar , Ltd.

Registered with
  • US (FDA)
D2P

3D Systems, Inc.

Registered with
  • US (FDA)
Dario Blood Glucose Monitoring System

LABSTYLE INNOVATIONS LTD.

Registered with
  • US (FDA)
  • AU (TGA)