# K252249: Extremity CT Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Mars Bioimaging, Ltd.
- Decided: Mar 13, 2026 after 238 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: 6 generations back to K973598 (1997). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160723: OnSight 3D Extremity System, Carestream Health, Inc. (2016) Summary page 5.

## Indications for use
The Extremity CT Imaging System is intended for x-ray computed tomography imaging of upper extremities of adult patients. The device is intended to be operated in a professional healthcare environment by qualified and trained healthcare professionals only.

Source page: https://510kreport.com/device/K252249
Methodology: https://510kreport.com/methodology