Viz CTP 1.1
by Viz.ai
Viz CTP 1.1 is a Class II device made by Viz.ai, cleared under FDA 510(k) K180161 on 20 Apr 2018 and listed in FDA GUDID since 22 Mar 2019 (UDI-DI 00811852030011), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00811852030011 | Date22 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180161 | Date20 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 00811852030011
- FDA 510(k) database K180161
Across registries
- FDA 510(k) K180161 decided 20 Apr 2018 Active
- FDA GUDID UDI-DI 00811852030011 listed 22 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K180161
- Listed FDA GUDID 00811852030011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Viz CTP
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.1
- Primary DI / UDI-DI
- 00811852030011
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- Not in Commercial Distribution
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