Viz CTP
by Viz.ai
510(k) K180161
Viz CTP is a Class II device made by Viz.ai, cleared under FDA 510(k) K180161 on 20 Apr 2018, 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 | NumberK180161 | Date20 Apr 2018 | StatusActive |
Official records
- FDA 510(k) database K180161
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Viz. Ai, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K180161
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 CTP 1.1 | 1.1 | 00811852030011 | — | No longer on the market |
| Viz CTP 1.2 | 1.2 | 00811852030066 | — | No longer on the market |
| Viz CTP 1.3 | 1.3 | 00811852030103 | — | No longer on the market |
| Viz CTP 1.4 | 1.4 | 00811852030141 | — | No longer on the market |
| Viz CTP Software | Viz CTP Software | 00811852030288 | — | On the market |
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