← Back to catalogue
Invivo Workspace Web Viewer
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SW-WV-15Model 1.5
Identity
- Trade Name
- InVivo Web Viewer FDA UDI
- Generic Name
- Radiology information system application software FDA UDI
- Device Name
- Invivo Workspace Web Viewer EUDAMEDInVivo Web Viewer is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT and MRI. FDA UDI
- Model / Reference
- 1.5 EUDAMEDSW-WV-15 EUDAMED1.0 FDA UDI
- Description
- InVivo Web Viewer is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT and MRI. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852060007105 EUDAMEDFDA UDI
- Basic UDI-DI
- 0852060007WebViewer16Q EUDAMED
- Direct Marketing DI
- 00852060007105 EUDAMED
- 510(k) Number
- K123519 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology information system application 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
- Germany 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
Invivo Workspace Web Viewer by Anatomage, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181926 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0852060007WebViewer16Q | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anatomage, Inc.
- EUDAMED SRN
- US-MF-000027423
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (3)
- EUDAMED abcdf548-8321-4713-ae6b-8fd5de8092fc 61 fields · synced Jul 24, 2026
- FDA UDI ee9ad105-06af-4814-bcab-9be3e7764d59 34 fields · synced May 30, 2026
- FDA 510(k) K181926 1 fields · synced May 18, 2026