SafeCT-29
by Medic Vision Imaging Solutions
510(k) K153331
SafeCT-29 is a medical device (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Medic Vision Imaging Solutions, cleared under FDA 510(k) K153331 on 17 May 2016, 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 | NumberK153331 | Date17 May 2016 | StatusActive |
Official records
- FDA 510(k) database K153331
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K153331
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 | |||
|---|---|---|---|---|
| SafeCT-29 1.0 | 1.0 | 07290016836202 | — | On the market |
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