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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
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)
  • Canada (Health Canada)
  • 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)
LungMaps

Siemens Healthineers AG

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
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)
Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

Registered with
  • US (FDA)
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)
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)
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

Siemens Healthcare GmbH

Registered with
  • US (FDA)
MAGNETOM Cima.X

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Cima.X Fit

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance , Ltd.

Registered with
  • US (FDA)
MAGNETOM Free.Max

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Shenzhen Magnetic Resonance , Ltd.

Registered with
  • US (FDA)
MAGNETOM Free.Max, MAGNETOM Free.Star

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Sola; MAGNETOM Altea

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise

Siemens Healthcare GmbH

Registered with
  • US (FDA)