Viz SDH
by Viz.ai, Inc.
510(k) K220439
Viz SDH is a Class II device made by Viz.ai, Inc., cleared under FDA 510(k) K220439 on 25 Jul 2022, 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 | NumberK220439 | Date25 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K220439
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- Withdrawn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 K220439
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 SDH (Viz Subdural) Viz SDH Software | Viz SDH Software | 00811852030271 | — | On the market |
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