|
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)
|
|
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 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)
|
|
FFRangio System
|
Cathworks, 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)
|
FFRct
Heartflow
Registered with
-
US
US (FDA)
-
CA
Canada (Health Canada)
|
Heartflow
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Fibresolve
|
Imvaria, 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)
|
|
Fibresolve (with PCCP)
|
Imvaria, 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)
|
FibriCheck
Qompium NV
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
AU
AU (TGA)
-
EU
EU (EUDAMED)
|
Qompium NV
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
FLASH EVD System (10-0002)
|
7D Surgical Ulc
|
✓
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)
|
|
FlightPlan for Embolization
|
Ge Medical Systems Scs
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
FlightPlan for Liver
|
Ge Medical Systems Scs
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
FluChip-8G Influenza A+B Assay
|
Indevr, 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)
|
|
Follicle Clarity
|
Cycle Clarity
|
✓
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)
|
|
Formus Hip
|
Formus Labs, Ltd.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
FractureDetect (FX)
|
Imagen Technologies, 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)
|
|
Galen™ Second Read™
|
Ibex Medical Analytics 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)
|
|
Gastric Alimetry
|
Alimetry , 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)
|
|
GBrain MRI
|
Galileo Cds, 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)
|
|
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
|
Geneseeq Technology, 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)
|
Genius AI Detection
Hologic Inc
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
|
Hologic Inc
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
Genius AI Detection 2.0
|
Hologic 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)
|
|
Genius AI Detection 2.0 with CC-MLO Correlation
|
Hologic 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)
|
|
"Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm"
|
Hologic 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)
|
|
GI Genius
|
Cosmo Artificial Intelligence - Ai, 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)
|
|
GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)
|
Cosmo Artificial Intelligence - Ai, 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)
|
|
GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)
|
Cosmo Artificial Intelligence - Ai, 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)
|
|
GI Genius System 100 and GI Genius System 200
|
Cosmo Artificial Intelligence - Ai, 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)
|
|
Gili Pro BioSensor (also known as "Gili BioSensor System")
|
Continuse Biometrics , 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)
|
|
Global Hypoperfusion Index (GHI) Algorithm
|
Edwards Lifesciences, LLC
|
✓
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)
|
|
GoLIF! Lumbar Interbody Fusion System
|
Getset Surgical, SA
|
✓
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)
|
|
GyriCalc (Version 1.0.0)
|
Neurospectrum Insights 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)
|
