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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
Monaco RTP System (6.3)

Elekta Solutions AB

Registered with
  • US (FDA)
MOZI TPS

Manteia Technologies Co., Ltd.

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
MPXA-2000

Medipixel, Inc.

Registered with
  • US (FDA)
MR 5300 and MR 7700 R11 MR Systems

Philips Medical Systems Nederlands B.V.

Registered with
  • US (FDA)
MRCAT brain

Philips Medical Systems MR Finland

Registered with
  • US (FDA)
MRCAT Head & Neck

PHILIPS OY

Registered with
  • US (FDA)
MR Contour DL

Ge Healthcare

Registered with
  • US (FDA)
  • EU (EUDAMED)
MRCP+ v1.0

Perspectum Diagnostics, Ltd.

Registered with
  • US (FDA)
MR Diffusion Perfusion Mismatch V1.0

Olea Medical

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
MR DWI/FLAIR Measurement V1.0

Olea Medical

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
MRI Planner

Spectronic Medical AB

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
MSKai

Mskai

Registered with
  • US (FDA)
MuscleView

Springbok, Inc.

Registered with
  • US (FDA)
MuscleView 2.0

Springbok, Inc. (Dba Springbok Analytics)

Registered with
  • US (FDA)
MVision AI Segmentation

MVision AI

Registered with
  • US (FDA)
Myocardial Strain Software Application

Circle Cardiovascular Imaging, Inc.

Registered with
  • US (FDA)
Myomics

Phantomics, Inc.

Registered with
  • US (FDA)
Myo Plus

Otto Bock Healthcare Products GmbH

Registered with
  • US (FDA)
  • UK (MHRA)
MyShoulder Planner (5.3SSWPL)

Medacta International S.A.

Registered with
  • US (FDA)
NAEOTOM Alpha

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
NaviCam ProScan

Ankon Technologies Co., Ltd.

Registered with
  • US (FDA)
Nelli (Version 7.11)

Neuro Event Labs Oy

Registered with
  • US (FDA)
NemoScan

Software Nemotec S.L.

Registered with
  • US (FDA)
Neosoma Brain Mets

Neosoma, Inc.

Registered with
  • US (FDA)
Nerveblox

Smart Alfa Teknoloji San. VE Tic. A.S.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Neuro.Al Algorithm

Terarecon,Inc.

Registered with
  • US (FDA)
NeuroICH

Neurocareai, Inc.

Registered with
  • US (FDA)
Neuro Insight V1.0

Olea Medical

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
NeuroMatch

Lvis Corporation

Registered with
  • US (FDA)
Neurophet AQUA

Neurophet., Inc.

Registered with
  • US (FDA)
Neurophet AQUA AD Plus

Neurophet., Inc.

Registered with
  • US (FDA)
Neurophet AQUA (V3.1)

Neurophet., Inc.

Registered with
  • US (FDA)
NEUROQUANT

Cortechs Labs, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
NeuroRPM

New Touch Digital, Inc.

Registered with
  • US (FDA)
NEUROShield

In-Med Prognostics L3c

Registered with
  • US (FDA)
NeuViz 128 Multi-slice CT Scanner System

Neusoft Medical Systems Co., Ltd.

Registered with
  • US (FDA)
  • AU (TGA)
NEVISENSE

Scibase AB

Registered with
  • US (FDA)
  • AU (TGA)
NinesAI

Nines, Inc.

Registered with
  • US (FDA)
NinesMeasure

Nines, Inc.

Registered with
  • US (FDA)
nordicMEDiVA

Nordicneurolab

Registered with
  • US (FDA)
Notal Vision Home Optical Coherence Tomography (OCT) System

Notal Vision, Inc.

Registered with
  • US (FDA)
NS-HGlio

Neosoma, Inc.

Registered with
  • US (FDA)
NuVasive Pulse System

Nu Vasive, Incorporated

Registered with
  • US (FDA)
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

Ninepoint Medical, Inc.

Registered with
  • US (FDA)
O-arm O2 Imaging System

Medtronic Navigation Inc

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
OEC One CFD

Ge Hualun Medical Systems Co. , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
OFIX MIS App

ORTHOFIX US LLC

Registered with
  • US (FDA)
Omni Legend

Ge Medical Systems Israel, Functional Imaging

Registered with
  • US (FDA)
Oncospace

Oncospace, Inc.

Registered with
  • US (FDA)