# K220175: GM85

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Apr 21, 2022 after 90 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: 17 generations back to K981556 (1998). 57 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181626: Digital Diagnostic Mobile X-ray System, Samsung Electronics Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K222353: GM85 (2022), 2 descendants of its own
- K242651: GM85 (2024), 0 descendants of its own
- K242478: GF85 (models GF85-3P, GF85-SP) (2024), 0 descendants of its own

## 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/K220175
Methodology: https://510kreport.com/methodology