Identity
- Trade Name
- Viz LVO EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Viz LVO EUDAMEDViz LVO v1.18 (2025-05-04) FDA UDI
- Model / Reference
- 081185203VIZLVOE6 EUDAMEDViz LVO Software FDA UDI
- Description
- Viz LVO v1.18 (2025-05-04) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811852030301 EUDAMEDFDA UDI
- Basic UDI-DI
- 081185203VIZLVOE6 EUDAMED
- Direct Marketing DI
- 00811852030301 EUDAMED
- FDA Product Code
- QAS FDA UDI
- EMDN Code
- Z12109082 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2080 FDA UDI
- Market of Registration
- Italy 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
No
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
Viz LVO by Viz.ai — 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 | 081185203VIZLVOE6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Viz.ai
- EUDAMED SRN
- US-MF-000024837
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (2)
- EUDAMED 2a8c6be8-dcd9-463c-9b81-520249509adf 61 fields · synced Jun 9, 2026
- FDA UDI e54d4b12-0b48-42fb-b5d1-44bf8c032056 34 fields · synced May 26, 2026