# K242651: GM85

- Pathway: 510(k) (Special)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Oct 1, 2024 after 27 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The GM85 Digital Mobile 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/K242651
Methodology: https://510kreport.com/methodology