# K123106: Digital Diagnostic X-Ray System Model Xgeo GU60A

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jun 20, 2013 after 261 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
No predicates in its family tree.
22 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)
- None. The FDA summary names its predicate without a number.
- (no number) Revolution XR/d: named in the summary without a submission number

## Most influential descendants
- K140332: Xgeo GU60A (2014), 21 descendants of its own
- K151685: GUA60A, GU60A-65 (2015), 20 descendants of its own
- 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

## Indications for use
The XGEO GU60A 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/K123106
Methodology: https://510kreport.com/methodology