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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
syngo.CT Coronary Cockpit

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 (VA41F)

Siemens Healthcare GmbH

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)
syngo.via RT Image Suite VC10

Varian Medical Systems inc

Registered with
  • US (FDA)
TAIMedImg DeepMets

Taiwan Medical Imaging Co., Ltd.

Registered with
  • US (FDA)
TAVIPILOT

Caranx Medical

Registered with
  • US (FDA)
TechCare Trauma

Milvue

Registered with
  • US (FDA)
Tempus ECG-AF

Tempus AI, Inc.

Registered with
  • US (FDA)
Tempus ECG-Low EF

Tempus AI, Inc.

Registered with
  • US (FDA)
Tempus Pixel

Arterys, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
TeraRecon Aorta.CT (1.1.0)

Terarecon,Inc.

Registered with
  • US (FDA)
TeraRecon Cardiac.Chambers.MR (1.0.0)

Terarecon,Inc.

Registered with
  • US (FDA)
TeraRecon Cardiovascular.Calcification.CT

Terarecon,Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
TeraRecon Neuro

Terarecon,Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Registered with
  • US (FDA)
The 5000 Compact Series Ultrasound Systems

Philips Ultrasound, Inc.

Registered with
  • US (FDA)
THINQ

Corticometrics, LLC

Registered with
  • US (FDA)
TipTraQ (TTQ001)

Pranaq Pte. , Ltd.

Registered with
  • US (FDA)
Tissue of Origin Test Kit-FFPE

Cancer Genetics, Inc.

Registered with
  • US (FDA)
TISSUE OF ORIGIN TEST KIT FFPE

Pathwork Diagnostics, Inc.

Registered with
  • US (FDA)
TMINI™ Miniature Robotic System

THINK Surgical, Inc.

Registered with
  • US (FDA)
TOMTEC-ARENA

TOMTEC IMAGING SYSTEMS GMBH

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
TransEnterix Senhance Surgical System

Transenterix, Inc.

Registered with
  • US (FDA)
Transpara

Screenpoint Medical B.V.

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
Transpara 1.7.0

Screenpoint Medical B.V.

Registered with
  • US (FDA)
Transpara 1.7.2

Screenpoint Medical B.V.

Registered with
  • US (FDA)
Transpara (2.1.0)

Screenpoint Medical B.V.

Registered with
  • US (FDA)
Transpara Density 1.0.0

Screenpoint Medical B.V.

Registered with
  • US (FDA)
TRAQinform IQ

Aiq Global, Inc.

Registered with
  • US (FDA)
TraumaCad Neo (1.1)

Brainlab SE

Registered with
  • US (FDA)
TribusConnect

Tribusmed Beheer BV

Registered with
  • US (FDA)
Trinias

Shimadzu Corp.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
TRIOS Dx (R1)

3Shape TRIOS AS

Registered with
  • US (FDA)
Triton System

Gauss Surgical, Inc.,

Registered with
  • US (FDA)
TriVerity

Inflammatix, Inc.

Registered with
  • US (FDA)
True Definition DL

Ge Healthcare Japan Corporation

Registered with
  • US (FDA)
True Enhance DL

Ge Healthcare Japan Corporation

Registered with
  • US (FDA)
TruPlan

Circle Cardiovascular Imaging Inc

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
TruPlan Computed Tomography (CT) Imaging Software

Circle Cardiovascular Imaging Inc

Registered with
  • US (FDA)
  • Canada (Health Canada)
TruSPECT Processing Station

Spectrum Dynamics Medical, Ltd.

Registered with
  • US (FDA)
TruSPECT Radiological Image Processing Station

Spectrum Dynamics Medical, Ltd.

Registered with
  • US (FDA)