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StrokeViewer Image Viewer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NLSV-CModel RESMD-C
Identity
- Trade Name
- StrokeViewer Image Viewer EUDAMEDStrokeViewer FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- ResolutionMD EUDAMEDThe device is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports. FDA UDI
- Model / Reference
- RESMD-C EUDAMEDNLSV-C EUDAMEDFDA UDI
- Description
- The device is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B037NLSVC0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B037RESMDCXM EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
StrokeViewer Image Viewer by ResolutionMD Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B037RESMDCXM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ResolutionMD, Inc.
- EUDAMED SRN
- CA-MF-000031810
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 9975a61c-48b9-45ed-997b-e66c74eb5c55 61 fields · synced Jul 11, 2026
- FDA UDI dd2e490c-dc0d-440f-b325-e83bc62daf1b 33 fields · synced May 30, 2026