|
EFAI RTSuite CT HN-Segmentation System
|
Ever Fortune.Ai, Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Eko Analysis Software
|
Eko Devices, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Eko Foundation Analysis Software with Transformers (EFAST)
|
Eko Health, Inc
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Eko Low Ejection Fraction Tool (ELEFT)
|
Eko Health, Inc
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Eko Murmur Analysis Software (EMAS)
|
Eko Devices, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
ElucidVivo A.3
|
Elucid Bioimaging, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Embrace
|
Empatica S.R.L.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Embryo Predict
|
Alife Health Inc
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
|
Elekta Solutions AB
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
|
Empatica S.R.L.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
eMurmur Heart AI
|
Csd Labs GmbH
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
eMurmur ID
|
Csd Labs GmbH
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
encevis (2.1)
|
AIT Austrian Institute of Technology GmbH
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EndoNaut
|
Therenva Sas
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EndoScreener
|
Chengdu Wision Medical Device Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
EndoTool SubQ
|
Monarch Medical Technologies
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Enhanced Boundary for PCCT
|
Ge Medical Systems, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EnsoSleep
|
ENSODATA, INC.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
ENT EM
Brainlab SE
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
|
Brainlab SE
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EpiMonitor
|
Empatica S.R.L.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
|
Philips Ultrasound, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EPIQ Series Diagnostic Ultrasound System
|
Philips Ultrasound, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
|
Philips Medical Systems, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
|
Philips Ultrasound, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
|
Philips Ultrasound, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
|
Varian Medical Systems inc
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
|
Varian Medical Systems inc
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR
|
Medtronic Cardiac Rhythm Disease Management
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EW10-EC02 Endoscopy Support Program
|
FUJIFILM Corporation
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
EyeArt
Eyenuk, Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
EU
EU (EUDAMED)
|
Eyenuk, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
EyeArt v2.2.0
|
Eyenuk, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EyeBOX
|
Oculogica, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EYE-SYNC
|
Syncthink, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
EZ3D-I, E3
|
Ewoosoft Co., Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Ezra Flash
|
Ezra Ai, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Ezra Plexo Software
|
Ezra Ai, Inc.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
FaceHeart Vitals Software Development Kit (FH vitals SDK)
|
Faceheart Corp.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Falcon HST
|
Compumedics Limited
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
FastStroke, CT Perfusion 4D
|
Ge Medical Systems Scs
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Felix NeuroAI System
|
Fasikl Incorporated
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
FEops HEARTguide
Feops NV
Registered with
-
US
US (FDA)
-
AU
AU (TGA)
-
EU
EU (EUDAMED)
|
Feops NV
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
FEops HEARTguide Simulation Application
|
Feops NV
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
|
Feops NV
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
FerriSmart Analysis System
|
Resonance Health Analysis Services Pty, Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Fetal EchoScan
|
Brightheart
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Fetal EchoScan (v1.1)
|
Brightheart
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Fetal EchoScan (v1.2)
|
Brightheart
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
FETOLY
Diagnoly
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
EU
EU (EUDAMED)
|
Diagnoly
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
FETOLY-HEART
Diagnoly
Registered with
-
US
US (FDA)
-
EU
EU (EUDAMED)
|
Diagnoly
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
FFRangio
|
Cathworks, Ltd.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
