# K153331: SafeCT-29

- Pathway: 510(k) (Traditional)
- Applicant: Medic Vision Imaging Solutions
- Decided: May 17, 2016 after 180 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K982349 (1998). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143400: SOMATOM Definition AS/AS+, Siemens Medical Solutions USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K170273: Z-DOSE29 (2017), 0 descendants of its own

## Indications for use
The SafeCT-29 is intended for providing Computed Tomography Dose Check feature to Computed Tomography X-ray systems. The SafeCT-29 is specifically indicated for providing the Computed Tomography Dose Check feature which notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose index is above the predefined thresholds, for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.

Source page: https://510kreport.com/device/K153331
Methodology: https://510kreport.com/methodology