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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
1CMR Pro

Mycardium AI Limited

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

23AndMe

Registered with
  • US (FDA)
3DXR

Ge Medical Systems Scs

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
3mensio Workstation

Pie Medical Imaging BV

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
6440 MyLabX90

Esaote, S.P.A.

Registered with
  • US (FDA)
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

Esaote, S.P.A.

Registered with
  • US (FDA)
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

Esaote, S.P.A.

Registered with
  • US (FDA)
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)

Esaote, S.P.A.

Registered with
  • US (FDA)
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

7D Surgical, Inc.

Registered with
  • US (FDA)
a2z-Unified-Triage

A2z Radiology Ai, Inc.

Registered with
  • US (FDA)
ABMD Software

HeartLung Corporation

Registered with
  • US (FDA)
aBSI

Exini Diagnostics AB

Registered with
  • US (FDA)
  • EU (EUDAMED)
Accelerate Pheno System, Accelerate PhenoTest BC Kit

ACCELERATE DIAGNOSTICS

Registered with
  • US (FDA)
Accipiolx

Maxq-Al , Ltd.

Registered with
  • US (FDA)
AccuContour

Xiamen Manteia Technology , Ltd.

Registered with
  • US (FDA)
AccuContour

Manteia Technologies Co., Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
AccuContour 4.0

Manteia Technologies Co., Ltd.

Registered with
  • US (FDA)
Accuro 3S

Rivanna Medical, LLC

Registered with
  • US (FDA)
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

Philips Medical Systems Nederland BV

Registered with
  • US (FDA)
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical, Inc.

Registered with
  • US (FDA)
ACR LAB Urine Analysis Test System

Healthy.Io, Ltd.

Registered with
  • US (FDA)
Acumen Assisted Fluid Management (AFM) Software Feature

Edwards Lifesciences, LLC

Registered with
  • US (FDA)
Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

Edwards Lifeciences, LLC

Registered with
  • US (FDA)
Acumen Hypotension Prediction Index (HPI) Feature Software

Edwards Lifesciences, LLC

Registered with
  • US (FDA)
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
ADAS 3D

Galgo Medical S.L

Registered with
  • US (FDA)
ADAS 3D

Adas3D Medical S.L.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Adravision Perio

Adra Corporation

Registered with
  • US (FDA)
Advanced Algorithms for Treatment Management Applications (AATMA)

Elekta Solutions AB

Registered with
  • US (FDA)
Advanced RBC Application

CellaVision AB

Registered with
  • US (FDA)
AEYE-DS

Aeye Health, Inc.

Registered with
  • US (FDA)
Ahead 300

Brainscope Company, Inc.

Registered with
  • US (FDA)
AHI System

Fifth Eye, Inc.

Registered with
  • US (FDA)
AI100 with Shonit

SigTuple Technologies Pvt Ltd

Registered with
  • US (FDA)
  • EU (EUDAMED)
AI4CMR v1.0

AI4MedImaging Medical Solutions SA

Registered with
  • US (FDA)
AI4CMR v2.0

AI4MedImaging Medical Solutions SA

Registered with
  • US (FDA)
AIAS Cephalon

Metamorphosis GmbH

Registered with
  • US (FDA)
AIBOLIT 3D+

Aibolit Technologies, LLC

Registered with
  • US (FDA)
aiCockpit AI Viewer

Fovia, Inc.

Registered with
  • US (FDA)
AI-CVD

HeartLung Corporation

Registered with
  • US (FDA)
AI-ECG Platform

Shenzhen Carewell Electronics Co., Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
AI-ECG Tracker

Shenzhen Carewell Electronics Co., Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
AI Metrics

Ai Metrics, LLC

Registered with
  • US (FDA)
AiMIFY (1.x)

Subtle Medical, Inc.

Registered with
  • US (FDA)
AIMI-Triage CXR PTX

Radlogics, Inc.

Registered with
  • US (FDA)
AiORTA - Plan

ViTAA Medical Solutions, Inc.

Registered with
  • US (FDA)
AiORTA - Plan v2.0

ViTAA Medical Solutions, Inc.

Registered with
  • US (FDA)
AI Platform 2.0 (AIP002)

Exo Imaging, Inc.

Registered with
  • US (FDA)
AI Platform 2.2 (AIP002)

Exo Imaging, Inc.

Registered with
  • US (FDA)