# K181626: Digital Diagnostic Mobile X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jul 20, 2018 after 30 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: 16 generations back to K981556 (1998). 56 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 67 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.

## Most influential descendants
- K183292: Topaz Mobile DR System (2019), 4 descendants of its own
- K220175: GM85 (2022), 3 descendants of its own
- K201124: TOPAZ Mobile DR System (2020), 3 descendants of its own
- K242015: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (2024), 2 descendants of its own
- K222353: GM85 (2022), 2 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/K181626
Methodology: https://510kreport.com/methodology