# K151685: GUA60A, GU60A-65

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jul 17, 2015 after 25 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: 2 generations back to K123106 (2013). 2 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140332: Xgeo GU60A, Samsung Electronics Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own
- K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (2018), 18 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K151685
Methodology: https://510kreport.com/methodology