# K143029: Digital Diagnostic X-ray System (GC80)

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Feb 4, 2015 after 106 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K862120 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140334: Xgeo GC80, Samsung Electronics Co., Ltd. (2014) Summary page 5.

## Recalls of this device
- Jun 22, 2017 · Class II · Z-0726-2018: An image was obtained with over exposure during a Thorax examination using the AEC function.

## Indications for use
The GC80 Series 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/K143029
Methodology: https://510kreport.com/methodology