# K160723: OnSight 3D Extremity System

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Aug 30, 2016 after 167 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: 5 generations back to K973598 (1997). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121418: Planmed Verity, Planmed OY (2013) Summary page 4.

## Most influential descendants
- K252249: Extremity CT Imaging System (2026), 0 descendants of its own

## Indications for use
The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 or over.

Source page: https://510kreport.com/device/K160723
Methodology: https://510kreport.com/methodology