# K162278: Digital Diagnostic Mobile X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Nov 15, 2016 after 92 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: 12 generations back to K981556 (1998). 41 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150097: GM60A-32S & GM60A-40S, Samsung Electronics Co., Ltd. (2015) Summary page 4.
- K160997: GC85A, Samsung Electronics Co., Ltd. (2016) Summary page 4.
- K123526: Clearread +Confirm, Riverain Technologies (2012) Summary page 4.

## Most influential descendants
- K171119: GM85 (2017), 22 descendants of its own
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own
- K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (2018), 18 descendants of its own
- K181626: Digital Diagnostic Mobile X-ray System (2018), 10 descendants of its own
- K181629: GC85A (2018), 5 descendants of its own

## Indications for use
The GM8S5 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/K162278
Methodology: https://510kreport.com/methodology