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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
OncoStudio (OS-01)

Oncosoft. Co., Ltd.

Registered with
  • US (FDA)
One Drop Blood Glucose Monitoring System

Agamatrix, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Onera SleepMap (SLEEPMAP)

Onera B.V.

Registered with
  • US (FDA)
OnQ Neuro

Cortechs Labs, Inc.

Registered with
  • US (FDA)
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform

Optellum Ltd

Registered with
  • US (FDA)
OptimMRI

Rebrain, Sas

Registered with
  • US (FDA)
  • EU (EUDAMED)
OptimMRI (v2)

Rebrain, Sas

Registered with
  • US (FDA)
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Abbott Medical

Registered with
  • US (FDA)
Opulus™ Lymphoma Precision

Roche Molecular Systems, Inc.

Registered with
  • US (FDA)
Ortho AI

Ortho Ai, LLC

Registered with
  • US (FDA)
OrthoNext Platform System

Orthofix Srl

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

Imagen Technologies, Inc.

Registered with
  • US (FDA)
OsteoSight™ Hip (v1)

Naitive Technologies, Ltd.

Registered with
  • US (FDA)
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Perimeter Medical Imaging Ai, Inc.

Registered with
  • US (FDA)
OTS Hip

Ortoma AB

Registered with
  • US (FDA)
  • AU (TGA)
Overjet Calculus Assist

Overjet, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Overjet Caries Assist

Overjet, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Overjet Caries Assist-Pediatric

Overjet, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Overjet CBCT Assist

Overjet, Inc.

Registered with
  • US (FDA)
Overjet Charting Assist

Overjet, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
Overjet Dental Assist

Overjet, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Overjet Image Enhancement Assist

Overjet, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Overjet Periapical Radiolucency Assist

Overjet, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Oxehealth Vital Signs

Oxehealth Limited

Registered with
  • US (FDA)
Oxevision Sleep Device

Oxehealth Limited

Registered with
  • US (FDA)
Paige Prostate

Paige.Ai

Registered with
  • US (FDA)
PAPNET (R) TESTING SYSTEM

Bd Diagnostics

Registered with
  • US (FDA)
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

Pathwork Diagnostics, Inc.

Registered with
  • US (FDA)
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE

Pathwork Diagnostics, Inc.

Registered with
  • US (FDA)
PeekMed web

Peek Health, S.A.

Registered with
  • US (FDA)
  • EU (EUDAMED)
Peerbridge Cor(TM) System

Peerbridge Health, Inc.

Registered with
  • US (FDA)
PeraMobile and PeraWatch

Perahealth, Inc.

Registered with
  • US (FDA)
PeraServer and PeraTrend

Perahealth, Inc.

Registered with
  • US (FDA)
PeriCALM Patterns 3.0

PERIGEN, INC.

Registered with
  • US (FDA)
Perin Health System (PHD80060-2)

Perin Health Devices, LLC

Registered with
  • US (FDA)
Personalized Physiology Analytics Engine software

Vgbio, Inc (Dba Physiq)

Registered with
  • US (FDA)
Personalized Therapy Comfort Settings (PTCS)

ResMed PTY Ltd

Registered with
  • US (FDA)
Persyst 14 EEG Review and Analysis Software

Persyst Development Corp.

Registered with
  • US (FDA)
PhantomMSK Trauma

Orthogrid Systems, Inc.

Registered with
  • US (FDA)
PhenoMATRIX

Copan WASP Srl

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Philips CT 3500

Philips Healthcare (Suzhou) Co., Ltd.

Registered with
  • US (FDA)
  • EU (EUDAMED)
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System

Philips Medical Systems, Inc.

Registered with
  • US (FDA)
Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

Registered with
  • US (FDA)
Photonova Spectra, Photonova Spectra Select

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
PhysCade System

Physcade, Inc.

Registered with
  • US (FDA)
physIQ Heart Rhythm and Respiratory Module

Physiq, Inc.

Registered with
  • US (FDA)
PIUR tUS Infinity

piur imaging GmbH

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
PIUR tUS inside

piur imaging GmbH

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

Algomedica

Registered with
  • US (FDA)
PMD-200

Medasense Biometrics Ltd

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