# K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: May 24, 2018 after 84 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: 15 generations back to K981556 (1998). 55 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163115: GC70, Samsung Electronics Co., Ltd. (2016) Summary page 11.
- K173828: GU60A & GU60A-65, Samsung Electronics Co., Ltd. (2018) Summary page 10.
- K140326: Xgeo GF50, Samsung Electronics Co., Ltd. (2014) Summary page 11.
- K151419: GF50A, Samsung Electronics Co., Ltd. (2015) Summary page 11.
- K153401: GR40CW, Samsung Electronics Co., Ltd. (2015) Summary page 11.
- K171119: GM85, Samsung Electronics Co., Ltd. (2017) Summary page 11.
- K172229: GC85A, Samsung Electronics Co., Ltd. (2017) Summary page 10.

## Most influential descendants
- K181626: Digital Diagnostic Mobile X-ray System (2018), 10 descendants of its own
- K181631: GR40CW (2018), 5 descendants of its own
- K183292: Topaz Mobile DR System (2019), 4 descendants of its own
- K220175: GM85 (2022), 3 descendants of its own
- K203188: ADD (2021), 3 descendants of its own

## Indications for use
The GC70 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. The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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. The GF50 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. The GF50A 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. The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. The GM85 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/K180543
Methodology: https://510kreport.com/methodology