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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
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

Bonraybio Co., Ltd.

Registered with
  • US (FDA)
Libby Echo:Prio

Dyad Medical, Inc.

Registered with
  • US (FDA)
Ligence Heart

Ligence Uab

Registered with
  • US (FDA)
Lightning Viewer

Nexsys Electronics Inc. Dba Medweb

Registered with
  • US (FDA)
Limbus Contour

Limbus Ai, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
LINQ II Insertable Cardiac Monitor

Medtronic, Inc

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application

Medtronic, Inc

Registered with
  • US (FDA)
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

Medtronic, Inc

Registered with
  • US (FDA)
LiverMultiScan

Perspectum Ltd

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
LiverMultiScan (LMSv3)

Perspectum Diagnostics, Ltd.

Registered with
  • US (FDA)
LiverMultiScan v5 (LMSv5)

Perspectum Ltd

Registered with
  • US (FDA)
LiverMultiScan (v6.0)

Perspectum Ltd

Registered with
  • US (FDA)
LiverSmart

Resonance Health Analysis Services Pty, Ltd.

Registered with
  • US (FDA)
Logicon Caries Detection Software

Carestream Dental, LLC

Registered with
  • US (FDA)
LOGIQ E10

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
LOGIQ E10s

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
LOGIQ E10s, LOGIQ Fortis

Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC

Registered with
  • US (FDA)
LOGIQ Fortis

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
LOGIQ Totus

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Loop System

Spry Health, Inc.

Registered with
  • US (FDA)
Loss of Pulse Detection

Fitbit, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Low Ejection Fraction AI-ECG Algorithm

Anumana, Inc.

Registered with
  • US (FDA)
LUMA CERVICAL IMAGING SYSTEM

Spectra Science

Registered with
  • US (FDA)
Lumify Diagnostic Ultrasound System

Philips Ultrasound, Inc.

Registered with
  • US (FDA)
  • EU (EUDAMED)
LumiNE US; Lumi

Augmedit B.V.

Registered with
  • US (FDA)
LUMINOS Q.namix T; LUMINOS Q.namix R

Siemens Medical Solutions

Registered with
  • US (FDA)
Lung AI (LAI001)

EXO S.A.

Registered with
  • US (FDA)
Lung-CAD

Imagen Technologies, Inc.

Registered with
  • US (FDA)
Lung Density Analysis

Imbio, LLC

Registered with
  • US (FDA)
LungQ 4

Thirona Corporation

Registered with
  • US (FDA)
LungQ Software

Thirona Corporation

Registered with
  • US (FDA)
LungQ v3.0.0

Thirona Corporation

Registered with
  • US (FDA)
Lung Vision

Bodyvision Medical , Ltd.

Registered with
  • US (FDA)
LungVision

Bodyvision Medical , Ltd.

Registered with
  • US (FDA)
Lung Vision System

Bodyvision Medical , Ltd.

Registered with
  • US (FDA)
Lunit INSIGHT CXR Triage

Lunit, Inc.

Registered with
  • US (FDA)
Lunit INSIGHT DBT

Lunit, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Lunit INSIGHT DBT v1.1

Lunit, Inc.

Registered with
  • US (FDA)
Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

Registered with
  • US (FDA)
Lunit INSIGHT MMG

Lunit, Inc.

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

Dia Imaging Analysis, Ltd.

Registered with
  • US (FDA)
LVivo Seamless

Dia Imaging Analysis, Ltd.

Registered with
  • US (FDA)
LVivo Software Application

Diacardio, Ltd.

Registered with
  • US (FDA)
LVivo Software Application

Dia Imaging Analysis, Ltd.

Registered with
  • US (FDA)
M1000 IMAGECHECKER

Hologic Inc

Registered with
  • US (FDA)
Maestro System (REF100)

Moon Surgical

Registered with
  • US (FDA)
MAGENTIQ-COLO (ME-APDS)

Magentiq Eye, Ltd.

Registered with
  • US (FDA)
MAGNETOM Amira, MAGNETOM Sempra

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Avanto Fit

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)