Identity
- Trade Name
- Viz CTP FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Viz CTP 1.2 FDA UDI
- Model / Reference
- 1.2 FDA UDI
- Description
- Viz CTP 1.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811852030066 FDA UDI
- 510(k) Number
- K180161 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Viz.ai
Sources (1)
- FDA UDI da658807-0030-48b9-9675-61d8d7507c5c 36 fields · synced Jun 9, 2026