# K181629: GC85A

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jul 20, 2018 after 30 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: 14 generations back to K981556 (1998). 45 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172229: GC85A, Samsung Electronics Co., Ltd. (2017) Summary page 4.
- K171119: GM85, Samsung Electronics Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K260481: GC85A (2026), 0 descendants of its own
- K242478: GF85 (models GF85-3P, GF85-SP) (2024), 0 descendants of its own
- K182183: GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A (2018), 0 descendants of its own
- K182647: GC70 (2018), 0 descendants of its own
- K182622: GU60A, GU60A-65 (2018), 0 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/K181629
Methodology: https://510kreport.com/methodology