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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
SpotLight/SpotLight Duo (with DLIR option)

Arineta , Ltd.

Registered with
  • US (FDA)
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

Arineta , Ltd.

Registered with
  • US (FDA)
S-scan Open (100001800)

Esaote, S.P.A.

Registered with
  • US (FDA)
STAR Apollo Mapping System

Rhythm Al, Ltd.

Registered with
  • US (FDA)
Stealth AXiS Cranial clinical application

Medtronic Navigation Inc

Registered with
  • US (FDA)
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application

Medtronic Navigation Inc

Registered with
  • US (FDA)
Stethee Pro 1, Stethee Pro Software System

M3Dicine Pty , Ltd.

Registered with
  • US (FDA)
Steth IO

Stratoscientific, Inc.

Registered with
  • US (FDA)
Stethophone Pro

Sparrow Acoustics, Inc.

Registered with
  • US (FDA)
Strain AI (SAI001)

EXO S.A.

Registered with
  • US (FDA)
StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging, Inc.

Registered with
  • US (FDA)
StrokeSENS LVO

Circle Neurovascular Imaging, Inc.

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

Nico-Lab B.V.

Registered with
  • US (FDA)
Study Watch

Verily Life Sciences, LLC

Registered with
  • US (FDA)
Study Watch with Irregular Pulse Monitor

Verily Life Sciences, LLC

Registered with
  • US (FDA)
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

Verily Life Sciences, LLC

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

Subtle Medical, Inc.

Registered with
  • US (FDA)
SubtleMR

Subtle Medical, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
SubtleMR (2.3.x)

Subtle Medical, Inc.

Registered with
  • US (FDA)
SubtlePET

Subtle Medical, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
SubtleSYNTH (1.x)

Subtle Medical, Inc.

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

Bench7, Inc.

Registered with
  • US (FDA)
SurgicalAR

Medivis, Inc.

Registered with
  • US (FDA)
Surgical Reality Viewer

MedicalVR BV

Registered with
  • US (FDA)
SurgiCount+ System

Stryker Instruments

Registered with
  • US (FDA)
SurgiTwin

Twinsight

Registered with
  • US (FDA)
SwiftMR

Airs Medical, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
SwiftSight-Brain

Airs Medical, Inc.

Registered with
  • US (FDA)
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Hyperfine, Inc.

Registered with
  • US (FDA)
Swoop® Portable MR Imaging® System

Hyperfine, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
Swoop® Portable MR Imaging® System (V2)

Hyperfine, Inc.

Registered with
  • US (FDA)
Synapse 3D Base Tools (V7.0)

FUJIFILM Corporation

Registered with
  • US (FDA)
Synapse 3D, Synapse 3D Base Tools v6.1

FUJIFILM Corporation

Registered with
  • US (FDA)
Synapse PACS (7.5)

Fujifilm Healthcare Americas Corporation

Registered with
  • US (FDA)
syngo Application Software

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
Syngo Carbon Clinicals

Siemens Healthcare GmbH

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Syngo Carbon Clinicals (VA41)

Siemens Healthineers

Registered with
  • US (FDA)
Syngo Carbon Enterprise Access (VA40A)

Siemens Healthcare GmbH

Registered with
  • US (FDA)
syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
syngo.CT Extended Functionality

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
syngo.CT Lung CAD

Siemens Medi Cal Solutions, Inc.

Registered with
  • US (FDA)
syngo.CT Lung CAD

Siemens Healthcare GmbH

Registered with
  • US (FDA)
  • Canada (Health Canada)
syngo.CT Lung CAD (Version VD30)

Siemens Healthcare GmbH

Registered with
  • US (FDA)
syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
Syngo Dynamics (Version VA40F)

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
syngo Dynamics (Version VA41D)

Siemens Healthcare GmbH

Registered with
  • US (FDA)
syngo.via MI WorkFlows, Scenium, syngo MBF

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
syngo.via MI Workflows, syngo MBF

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
syngo.via RT Image Suite

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)