# K182622: GU60A, GU60A-65

- Pathway: 510(k) (Special)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Oct 23, 2018 after 29 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: 16 generations back to K981556 (1998). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85, Samsung Electronics Co., Ltd. (2018) Summary page 4.
- K181629: GC85A, Samsung Electronics Co., Ltd. (2018) Summary page 4.

## 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/K182622
Methodology: https://510kreport.com/methodology