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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.

1,330 devices · when each source was last refreshed

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

Device
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)
  • EU (EUDAMED)
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)
DASI Dimensions (V1.0)

Dasi Simulations

Registered with
  • US (FDA)
Data Analysis Facilitation Suite (DAFS)

Voronoi Health Analytics Incorporated

Registered with
  • US (FDA)
DeepBT Detector-Plus

Aitewan Biomedical Technology, Inc.

Registered with
  • US (FDA)
Deep Capsule® (Deep Capsule US)

Digestaid - Artificial Intelligence Development SA

Registered with
  • US (FDA)
DeepCatch

Medical IP Co., Ltd.

Registered with
  • US (FDA)
DeepContour (V1.0)

Wisdom Technologies., Inc.

Registered with
  • US (FDA)
DeepCT

Deep01 Limited

Registered with
  • US (FDA)
DEEPECHO

Deepecho

Registered with
  • US (FDA)
DeepFoqus (DeepFoqus-Accelerate)

Foqus Technologies, Inc.

Registered with
  • US (FDA)
DeepHealth ProstateAI

Quantib B.V.

Registered with
  • US (FDA)
Deep Learning Image Reconstruction

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Deep Learning Image Reconstruction

Ge Healthcare Japan Corporation

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Deep Learning Image Reconstruction for Gemstone Spectral Imaging

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

Registered with
  • US (FDA)
DeepRESP

Nox Medical Ehf

Registered with
  • US (FDA)
DeepRhythmAI

Medicalgorithmics SP Z.O.O.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
DeepTek CXR Analyzer v1.0

Deeptek Medical Imaging Private Limited

Registered with
  • US (FDA)
DEEPVESSEL FFR

Keyamed Na, Inc.

Registered with
  • US (FDA)
DEEPVESSEL Plaque

Keya Medical Technology Co., Ltd.

Registered with
  • US (FDA)
DeepView AI® System

Spectralmd, Inc.

Registered with
  • US (FDA)
DeepXray

Alpha Intelligence Manifolds, Inc.

Registered with
  • US (FDA)
DeepXray Spina

Alpha Intelligence Manifolds, Inc.

Registered with
  • US (FDA)
Definium Tempo Select

Ge Hualun Medical Systems Co. , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Delivery Date AI

Ultrasound AI

Registered with
  • US (FDA)
DELTAVIEW MODEL 2.1

Riverain Medical Group,Llc

Registered with
  • US (FDA)
DenSeeMammo

Statlife

Registered with
  • US (FDA)
densitas® densityAI™

Densitas, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
DentalMonitoring

Dental Monitoring Sas

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Denti.AI Detect

Denti.Ai Technology, Inc.

Registered with
  • US (FDA)
DermaSensor

Dermasensor, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Diagnocat

Dgnct, LLC

Registered with
  • US (FDA)
  • AU (TGA)
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

CellaVision AB

Registered with
  • US (FDA)
Digital Color Doppler Ultrasound System (P60 Series)

Sonoscape Medical Corp.

Registered with
  • US (FDA)
DIP/U.S. Urine Analysis Test System

Healthy.Io, Ltd.

Registered with
  • US (FDA)
Discovery MI Gen2

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
  • EU (EUDAMED)
DM-Density

Densitas, Inc.

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