HaRi
Start Free→

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
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)
MAGNETOM Terra; MAGNETOM Terra.X

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Viato.Mobile

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

Siemens Medical Solutions USA, Inc.

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

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
Magnifico Open (100009900)

Esaote, S.P.A.

Registered with
  • US (FDA)
MALDI BIOTYPER CA (MBT-CA) SYSTEM

Bruker Daltonics GmbH & Co KG

Registered with
  • US (FDA)
MAMMOMAT B.brilliant with Tomosynthesis Option

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MammoScreen

Therapixel

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
MammoScreen 2.0

Therapixel

Registered with
  • US (FDA)
MammoScreen® (3)

Therapixel

Registered with
  • US (FDA)
MammoScreen® (4)

Therapixel

Registered with
  • US (FDA)
MammoScreen BD

Therapixel

Registered with
  • US (FDA)
MarginProbe System

Dilon Medical Technologies, Ltd.

Registered with
  • US (FDA)
Masimo SafetyNet

Masimo Corp.

Registered with
  • US (FDA)
  • AU (TGA)
MATRx plus

ZEPHYR SLEEP TECHNOLOGIES

Registered with
  • US (FDA)
MaxFOV 2

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Mazor X System (Mazor X Stealth Edition)

Mazor Robotics , Ltd.

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

Magentiq Eye, Ltd.

Registered with
  • US (FDA)
  • EU (EUDAMED)
MediAI-BA

Crescom Co., Ltd.

Registered with
  • US (FDA)
Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies

Registered with
  • US (FDA)
Medical Image Post-processing Software (uOmnispace.CT)

Shanghai United Imaging Healthcare Co., Ltd.

Registered with
  • US (FDA)
Medihub Prostate

JLK, Inc.

Registered with
  • US (FDA)
MEDIP PRO

Medical IP Co., Ltd.

Registered with
  • US (FDA)
MEDO ARIA

Medo.Ai

Registered with
  • US (FDA)
MEDO-Thyroid

Medo DX Pte. , Ltd.

Registered with
  • US (FDA)
MELAFIND

Strata Skin Sciences, Inc.

Registered with
  • US (FDA)
Merge PACS

Merge Healthcare Incorporated

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Methinks CTA Stroke

Methinks Software SL

Registered with
  • US (FDA)
Methinks NCCT Stroke

Methinks Software SL

Registered with
  • US (FDA)
MeVis Liver Suite

Mevis Medical Solutions AG

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Micro C Medical Imaging System, M01

OXOS MEDICAL, INC.

Registered with
  • US (FDA)
MICSI-RMT

Microstructure Imaging, Inc.

Registered with
  • US (FDA)
MIMOSA Imager

Mimosa Diagnostics, Inc.

Registered with
  • US (FDA)
Minuteful - kidney test

Healthy.Io, Ltd.

Registered with
  • US (FDA)
MI View&GO

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Momentum Spine

Momentum Health, Inc.

Registered with
  • US (FDA)