# K153401: GR40CW

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Dec 21, 2015 after 27 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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: 7 generations back to K862120 (1986). 14 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152094: GR40CW, Samsung Electronics Co., Ltd. (2015) Summary page 4.
- K102587: LLX240AB01, Samsung Mobile Display Co., Ltd. (2010) Summary page 4.

## Most influential descendants
- 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
- K181631: GR40CW (2018), 5 descendants of its own
- K183292: Topaz Mobile DR System (2019), 4 descendants of its own
- K220175: GM85 (2022), 3 descendants of its own

## Indications for use
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K153401
Methodology: https://510kreport.com/methodology