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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
Radify Triage

Envisionit Deepai, Ltd.

Registered with
  • US (FDA)
Radiography 7300 C

Philips Medical Systems Dmc GmbH

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

Synapsica

Registered with
  • US (FDA)
Radiomics App v1.0

Microsoft Corporation

Registered with
  • US (FDA)
Rapid

Ischemaview, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
Rapid (6.0)

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid Aneurysm Triage and Notification

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid Aortic Measurements

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid ASPECTS

Ischemaview, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Rapid ASPECTS (v3)

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid CTA 360

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid ICH

Ischemaview, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Rapid LVO

Ischemaview, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Rapid MLS

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid NCCT Stroke

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid Neuro3D

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid Obstructive Hydrocephalus, Rapid OH

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid PE Triage and Notification (PETN)

Ischemaview, Inc.

Registered with
  • US (FDA)
Rapid RV/LV

Ischemaview, Inc.

Registered with
  • US (FDA)
RAPIDSCREEN RS-2000

Riverain Medical Group,Llc

Registered with
  • US (FDA)
Rapid SDH

Ischemaview, Inc.

Registered with
  • US (FDA)
RayCare 2.3

RaySearch Laboratories AB (PUBL)

Registered with
  • US (FDA)
RAYDENT SW

Ray Co., Ltd.

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

RaySearch Laboratories AB (PUBL)

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
RayStation 10.1

RaySearch Laboratories AB (PUBL)

Registered with
  • US (FDA)
RayStation 11.0

RaySearch Laboratories AB (PUBL)

Registered with
  • US (FDA)
RayStation 11B

RaySearch Laboratories AB (PUBL)

Registered with
  • US (FDA)
  • UK (MHRA)
RayStation 12A

RaySearch Laboratories AB (PUBL)

Registered with
  • US (FDA)
  • UK (MHRA)
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

RaySearch Laboratories AB (PUBL)

Registered with
  • US (FDA)
Rayvolve

Azmed Sas

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
Rayvolve LN

Azmed Sas

Registered with
  • US (FDA)
Rayvolve PTX-PE

Azmed Sas

Registered with
  • US (FDA)
RBknee

Radiobotics Aps

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Red Dot

Behold.Ai Technologies Limited

Registered with
  • US (FDA)
Relu Creator

Relu BV

Registered with
  • US (FDA)
  • EU (EUDAMED)
RemedyLogic AI MRI Lumbar Spine Reader

Remedy Logic, Inc.

Registered with
  • US (FDA)
REMI AI Discrete Detection Module

Epitel, Inc.

Registered with
  • US (FDA)
REMI-AI Rapid Detection Module (REMI-AI RDM)

Epitel, Inc.

Registered with
  • US (FDA)
RevealAI-Lung

Precision Medical Ventures Inc dba RevealDx

Registered with
  • US (FDA)
  • UK (MHRA)
Reveal LINQ

Medtronic, Inc

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System

Medtronic, Inc

Registered with
  • US (FDA)
Revolution Ascend

Ge Healthcare Japan Corporation

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Revolution Ascend Sliding

Ge Hangwei Medical Systems Co., Ltd.

Registered with
  • US (FDA)
Revolution Vibe

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Rho

16 BIT INC.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
RhythmAnalytics

Biofourmis Singapore Pte., Ltd.

Registered with
  • US (FDA)
RightEye Vision System

Righteye, LLC

Registered with
  • US (FDA)
Rooti Rx ECG Event Recorder, Rooti Link APP Software

Rooti Labs Limited.

Registered with
  • US (FDA)
RS85 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

Registered with
  • US (FDA)
  • Canada (Health Canada)
RSI-MRI+

Multimodal Imaging Services Corporation (Dba Healthlytix)

Registered with
  • US (FDA)