|
Spine Auto Views
|
Ge Medical Systems Scs
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Spine CAMP™
|
Medical Metrics, 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)
|
|
Spine CAMP™ (1.1)
|
Medical Metrics, 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)
|
|
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
|
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)
|
|
SpineUs™ System
|
Verdure Imaging
|
✓
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)
|
|
SpotLight/SpotLight Duo (with DLIR option)
|
Arineta , 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)
|
|
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
|
Arineta , 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)
|
|
S-scan Open (100001800)
|
Esaote, S.P.A.
|
✓
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)
|
|
STAR Apollo Mapping System
|
Rhythm Al, 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)
|
|
Stealth AXiS Cranial clinical application
|
Medtronic Navigation 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)
|
|
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
|
Medtronic Navigation 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)
|
|
Stethee Pro 1, Stethee Pro Software System
|
M3Dicine 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)
|
|
Steth IO
|
Stratoscientific, 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)
|
|
Stethophone Pro
|
Sparrow Acoustics, 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)
|
|
Strain AI (SAI001)
|
EXO S.A.
|
✓
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)
|
|
StrokeSENS ASPECTS Software Application
|
Circle Cardiovascular Imaging 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)
|
|
StrokeSENS LVO
|
Circle Neurovascular Imaging, 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)
|
|
StrokeViewer Perfusion
|
Nico-Lab 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)
|
|
Study Watch
|
Verily Life Sciences, 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)
|
|
Study Watch with Irregular Pulse Monitor
|
Verily Life Sciences, 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)
|
|
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
|
Verily Life Sciences, 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)
|
|
SubtleHD (1.x)
|
Subtle Medical, 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)
|
|
SubtleHD-CT (1.x)
|
Subtle Medical, 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)
|
|
SubtleHD-PET (1.x)
|
Subtle Medical, 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)
|
|
SubtleMR
|
Subtle Medical, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SubtleMR (2.3.x)
|
Subtle Medical, 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)
|
|
SubtlePET
|
Subtle Medical, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
—
Not registered with EU (EUDAMED)
|
|
SubtleSYNTH (1.x)
|
Subtle Medical, 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)
|
|
SugarBug (1.x)
|
Bench7, 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)
|
|
SurgicalAR
|
Medivis, 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)
|
|
Surgical Reality Viewer
|
MedicalVR 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)
|
|
SurgiCount+ System
|
Stryker Instruments
|
✓
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)
|
|
SurgiTwin
|
Twinsight
|
✓
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)
|
SwiftMR
Airs Medical, Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
CA
Canada (Health Canada)
-
AU
AU (TGA)
-
EU
EU (EUDAMED)
|
Airs Medical, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
SwiftSight-Brain
|
Airs Medical, 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)
|
|
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
|
Hyperfine, 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)
|
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Registered with
-
US
US (FDA)
-
UK
UK (MHRA)
-
AU
AU (TGA)
-
EU
EU (EUDAMED)
|
Hyperfine, Inc.
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
—
Not registered with Canada (Health Canada)
|
✓
Registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Swoop® Portable MR Imaging® System (V2)
|
Hyperfine, 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)
|
|
Synapse 3D Base Tools (V7.0)
|
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)
|
|
Synapse 3D Base Tools (V7.2)
|
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)
|
|
Synapse 3D, Synapse 3D Base Tools v6.1
|
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)
|
|
Synapse Lung Nodule AI
|
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)
|
|
Synapse PACS (7.5)
|
Fujifilm Healthcare Americas 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)
|
|
Synapse PACS (7.6.0)
|
Fujifilm Healthcare Americas 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)
|
|
syngo Application Software
|
Siemens Medical Solutions USA, 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)
|
|
Syngo Carbon Clinicals
|
Siemens Healthcare GmbH
|
✓
Registered with US (FDA)
|
✓
Registered with UK (MHRA)
|
✓
Registered with Canada (Health Canada)
|
—
Not registered with AU (TGA)
|
✓
Registered with EU (EUDAMED)
|
|
Syngo Carbon Clinicals (VA41)
|
Siemens Healthineers AG
|
✓
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)
|
|
Syngo Carbon Enterprise Access (VA40A)
|
Siemens Healthcare 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)
|
|
syngo.CT Brain Hemorrhage
|
Siemens Medical Solutions USA, 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)
|
|
syngo.CT CaScoring
|
Siemens Medical Solutions USA, 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)
|
