Viz AAA
by Viz.ai, Inc.
510(k) K223443
Viz AAA is a Class II device made by Viz.ai, Inc., cleared under FDA 510(k) K223443 on 17 Mar 2023, 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 | FDA 510(k)SESE | NumberK223443 | Date17 Mar 2023 | StatusActive |
Official records
- FDA 510(k) database K223443
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QFM
- FDA applicant
- Viz. Ai, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2080
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K223443
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Viz AAA Software | Viz AAA Software | 00811852030325 | — | On the market |
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