# K160997: GC85A

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jul 6, 2016 after 86 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K981556 (1998). 29 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150165: GC85A, Samsung Electronics Co., Ltd. (2015) Summary page 4.
- K141765: FDR D-Evo Flat Panel Detector System, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.
- K141837: DRX-Evolution, Carestream Health, Inc. (2015) Summary page 4.

## Most influential descendants
- K163115: GC70 (2016), 23 descendants of its own
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own
- K171119: GM85 (2017), 22 descendants of its own
- K172229: GC85A (2017), 21 descendants of its own
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own

## Indications for use
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K160997
Methodology: https://510kreport.com/methodology