Viz ICH
by Viz.ai 2 variants
510(k) K193658
Viz ICH is a Class II device made by Viz.ai, cleared under FDA 510(k) K193658 on 18 Mar 2020, 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 | NumberK193658 | Date18 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K193658
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- Withdrawn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
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