# K123098: Xgeo GC80

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jan 18, 2013 after 108 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: 4 generations back to K862120 (1986). 5 ancestors in all.
48 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012389: Revolution XR/D Digital Radiographic Imaging System, Ge Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K140334: Xgeo GC80 (2014), 40 descendants of its own
- K150165: GC85A (2015), 36 descendants of its own
- K160997: GC85A (2016), 26 descendants of its own
- K142492: GM60A-32S, GM60A-40S (2014), 25 descendants of its own
- K150097: GM60A-32S & GM60A-40S (2015), 24 descendants of its own

## Indications for use
The XGEO GC8O 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/K123098
Methodology: https://510kreport.com/methodology