Viz ICH
by Viz.ai 2 variants
510(k) K210209
Viz ICH is a Class II device made by Viz.ai, cleared under FDA 510(k) K210209 on 23 Mar 2021, 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 | NumberK210209 | Date23 Mar 2021 | StatusActive |
Official records
- FDA 510(k) database K210209
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QAS
- 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 K210209
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 ICH Software | Viz ICH Software | 00811852030318 | — | On the market |
| Viz ICH Software | Viz ICH Software | 00811852030370 | — | On the market |
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