|
syngo.via RT Image Suite VC10
|
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)
|
|
TAIMedImg DeepMets
|
Taiwan Medical Imaging 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)
|
|
TAVIPILOT
|
Caranx Medical
|
✓
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)
|
|
TechCare Trauma
|
Milvue
|
✓
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)
|
|
Tempus ECG-AF
|
Tempus 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)
|
|
Tempus ECG-Low EF
|
Tempus 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)
|
Tempus Pixel
Arterys, Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
-
EU
EU (EUDAMED)
|
Arterys, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
TeraRecon Aorta.CT (1.1.0)
|
Terarecon,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)
|
|
TeraRecon Cardiac.Chambers.MR (1.0.0)
|
Terarecon,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)
|
TeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
-
EU
EU (EUDAMED)
|
Terarecon,Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
TeraRecon Neuro
Terarecon,Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
-
EU
EU (EUDAMED)
|
Terarecon,Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
|
Shenzhen Mindray Bio-Medical Electronics 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)
|
|
The 5000 Compact Series 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)
|
|
THINQ
|
Corticometrics, 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)
|
|
TipTraQ (TTQ001)
|
Pranaq Pte. , 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)
|
|
Tissue of Origin Test Kit-FFPE
|
Cancer Genetics, 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)
|
|
TISSUE OF ORIGIN TEST KIT FFPE
|
Pathwork Diagnostics, 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)
|
|
TMINI™ Miniature Robotic System
|
THINK Surgical, 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)
|
|
TOMTEC-ARENA
|
TOMTEC IMAGING SYSTEMS GMBH
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
TransEnterix Senhance Surgical System
|
Transenterix, 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)
|
|
Transpara
|
Screenpoint Medical B.V.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Transpara 1.7.0
|
Screenpoint Medical B.V.
|
✓
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)
|
|
Transpara 1.7.2
|
Screenpoint Medical B.V.
|
✓
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)
|
|
Transpara (2.1.0)
|
Screenpoint Medical B.V.
|
✓
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)
|
|
Transpara Density 1.0.0
|
Screenpoint Medical B.V.
|
✓
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)
|
|
TRAQinform IQ
|
Aiq Global, 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)
|
|
TraumaCad Neo (1.1)
|
Brainlab SE
|
✓
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)
|
|
TribusConnect
|
Tribusmed Beheer BV
|
✓
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)
|
Trinias
Shimadzu Corp.
Registered with
-
US
US (FDA)
-
CA
Canada (Health Canada)
-
EU
EU (EUDAMED)
|
Shimadzu Corp.
|
✓
Registered with US (FDA)
|
—
Not registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Triton System
|
Gauss Surgical, 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)
|
|
TriVerity
|
Inflammatix, 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)
|
|
True Definition DL
|
Ge Healthcare Japan 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)
|
|
True Enhance DL
|
Ge Healthcare Japan 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)
|
|
TruPlan
|
Circle Cardiovascular Imaging, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
TruPlan Computed Tomography (CT) Imaging Software
|
Circle Cardiovascular Imaging, 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)
|
|
TruSPECT Processing Station
|
Spectrum Dynamics Medical, 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)
|
|
TruSPECT Radiological Image Processing Station
|
Spectrum Dynamics Medical, 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)
|
|
TumorSight Viz
|
SimBioSys, 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)
|
|
Tyto Insights for Crackles Detection
|
Tyto Care , 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)
|
|
Tyto Insights for Eardrum Bulging Detection
|
Tyto Care , 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)
|
|
Tyto Insights for Rhonchi Detection
|
Tyto Care , 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)
|
|
Tyto Insights for Wheeze Detection
|
Tyto Care , 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)
|
|
Tyto Stethoscope
|
Tyto Care , 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)
|
|
Tyto Stethoscope (G3)
|
Tyto Care , 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)
|
|
uAI Easy Triage ICH
|
Shanghai United Imaging Intelligence 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)
|
|
uAI EasyTriage-Rib
|
Shanghai United Imaging Intelligence 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)
|
|
uAI Portal
|
Shanghai United Imaging Intelligence 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)
|
|
uAngio AVIVA CX
|
Shanghai United Imaging Healthcare 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)
|
|
uCT 550
|
Shanghai United Imaging Healthcare 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)
|
|
uCT 780
|
Shanghai United Imaging Healthcare 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)
|
