Identity
- Trade Name
- Viz CTP EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Viz CTP EUDAMEDViz CTP v1.15 (2025-09-03) FDA UDI
- Model / Reference
- 081185203VIZCTPCM EUDAMEDViz CTP Software FDA UDI
- Description
- Viz CTP v1.15 (2025-09-03) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811852030288 EUDAMEDFDA UDI
- Basic UDI-DI
- 081185203VIZCTPCM EUDAMED
- Direct Marketing DI
- 00811852030288 EUDAMED
- 510(k) Number
- K180161 FDA UDI
- FDA Product Code
- LLZ 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
- 892.2050 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 CTP 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 | 081185203VIZCTPCM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Viz.ai
- EUDAMED SRN
- US-MF-000024837
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (2)
- EUDAMED 51498736-a151-4c34-b976-73fce40c011f 61 fields · synced Jul 10, 2026
- FDA UDI 8c0344cf-c28a-40ea-a6bb-e3b6bdc86612 35 fields · synced May 30, 2026