HaRi
Start Free→

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.

1,330 devices · when each source was last refreshed

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

Device
Clarius OB AI

Clarius Mobile Health Corp.

Registered with
  • US (FDA)
  • Canada (Health Canada)
Clarius Prostate AI

Clarius Mobile Health Corp.

Registered with
  • US (FDA)
  • Canada (Health Canada)
Clarius Ultrasound Scanner

Clarius Mobile Health Corp.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Clarius Ultrasound System

Clarius Mobile Health Corp.

Registered with
  • US (FDA)
  • Canada (Health Canada)
CLARUS

Carl Zeiss Meditec AG

Registered with
  • US (FDA)
  • UK (MHRA)
CLARUS 700

Carl Zeiss Meditec AG

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
ClearPoint Maestro Brain Model

ClearPoint Neuro Inc

Registered with
  • US (FDA)
ClearPoint System (Software Version 2.2)

ClearPoint Neuro Inc

Registered with
  • US (FDA)
ClearPoint System (Software Version 3.0)

ClearPoint Neuro Inc

Registered with
  • US (FDA)
CLEARREAD +CONFIRM

Riverain Technologies

Registered with
  • US (FDA)
  • Canada (Health Canada)
ClearRead CT

Riverain Technologies

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
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)
CMN Capillary Function with Oncology Virtual Expert

Cercare Medical AS

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)
CoLumbo C-Spine

Smart Soft Healthcare AD

Registered with
  • US (FDA)
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 ProtégéAI

Mim Software, Inc.

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

Mim Software, Inc.

Registered with
  • US (FDA)
  • EU (EUDAMED)
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 Enteric Tube Positioning 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)