Viz AAA Software
by Viz.ai
Viz AAA Software is a Class II device made by Viz.ai, cleared under FDA 510(k) K223443 on 17 Mar 2023 and listed in FDA GUDID since 22 May 2023 (UDI-DI 00811852030325), active 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 | Number00811852030325 | Date22 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223443 | Date17 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 00811852030325
- FDA 510(k) database K223443
Across registries
- FDA 510(k) K223443 decided 17 Mar 2023 Active
- FDA GUDID UDI-DI 00811852030325 listed 22 May 2023 Listed
Timeline
- Cleared FDA 510(k) K223443
- Listed FDA GUDID 00811852030325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Viz AAA
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- Viz AAA Software
- Primary DI / UDI-DI
- 00811852030325
- 510(k) Number
- FDA product code
- QFM
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2080
- GUDID distribution status
- In Commercial Distribution
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