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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
APPRAISE-HRI

The Surgeon General, Department of the Army (Tsg-Da)

Registered with
  • US (FDA)
aprevo® Digital Segmentation

Carlsmed, Inc.

Registered with
  • US (FDA)
aPROMISE

Exini Diagnostics AB

Registered with
  • US (FDA)
  • EU (EUDAMED)
aPROMISE X

Exini Diagnostics AB

Registered with
  • US (FDA)
Aquilion Exceed LB

Canon Medical Systems Corporation

Registered with
  • US (FDA)
  • UK (MHRA)
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion ONE (TSX-305A/6) V8.9 with AiCE

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion ONE (TSX-308A/3) V1.5

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Precision (TSX-304A/4) V10.10 with AiCE

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Precision (TSX-304A/4) V10.14 with AiCE

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Serve SP (TSX-307B/1) V1.3

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion ServeSP (TSX-307B) V2.0

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Aquilion Serve (TSX-307A/1) V1.3

Canon Medical Systems Corporation

Registered with
  • US (FDA)
ARTAssistant

Manteia Technologies Co., Ltd.

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

Artera Inc

Registered with
  • US (FDA)
Arterys Cardio DL

Arterys, Inc.

Registered with
  • US (FDA)
Arterys MICA

Arterys, Inc.

Registered with
  • US (FDA)
Arterys Oncology DL

Arterys, Inc.

Registered with
  • US (FDA)
ART-Plan

Therapanacea

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
ART-Plan (v.2.2.0)

Therapanacea

Registered with
  • US (FDA)
ART-Plan+ (v.3.0.0)

Therapanacea

Registered with
  • US (FDA)
ART-Plan+ (v3.1.0)

Therapanacea

Registered with
  • US (FDA)
ARVIS® Shoulder

Kico Knee Innovation Company Pty Limited

Registered with
  • US (FDA)
ARVIS® Shoulder

Insight Medical Systems, Inc.

Registered with
  • US (FDA)
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

Abbott GmbH

Registered with
  • US (FDA)
Assert-IQ (DM5100)

Abbott Medical

Registered with
  • US (FDA)
ASSURE Wearable ECG

Kestra Medical Technologies, Inc.

Registered with
  • US (FDA)
Athelas Home

ATHELAS INC.

Registered with
  • US (FDA)
Athelas One

ATHELAS INC.

Registered with
  • US (FDA)
  • Canada (Health Canada)
AT-Patch (ATP-C130/ATP-C70)

Atsens Co., Ltd.

Registered with
  • US (FDA)
Atrial Fibrillation History Feature

Apple, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
AudaxCeph Cephalogram Analysis Software

Audax d.o.o.

Registered with
  • US (FDA)
Aurora

ENSODATA, INC.

Registered with
  • US (FDA)
Aurora

GE MEDICAL SYSTEMS ISRAEL LTD.

Registered with
  • US (FDA)
AusculThing ACC

Ausculthing OY

Registered with
  • US (FDA)
AUTION EYE AI-4510 Urine Particle Analysis System

Arkray, Inc.

Registered with
  • US (FDA)
Auto 3D Bladder Volume Tool

Butterfly Network, Inc.

Registered with
  • US (FDA)
AutoContour

Radformation

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
AutoContour Model RADAC V2

Radformation

Registered with
  • US (FDA)
AutoContour Model RADAC V3

Radformation

Registered with
  • US (FDA)
AutoContour (Model RADAC V4)

Radformation

Registered with
  • US (FDA)
AutoContour (RADAC V5)

Radformation

Registered with
  • US (FDA)