# K242478: GF85 (models GF85-3P, GF85-SP)

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Sep 19, 2024 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: 19 generations back to K981556 (1998). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181629: GC85A, Samsung Electronics Co., Ltd. (2018) Summary page 5.
- K222353: GM85, Samsung Electronics Co., Ltd. (2022) Summary page 5.

## Indications for use
The GF85 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/K242478
Methodology: https://510kreport.com/methodology