# K181631: GR40CW

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jul 20, 2018 after 30 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: 16 generations back to K981556 (1998). 56 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 62 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.
- K171119: GM85, Samsung Electronics Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K203188: ADD (2021), 3 descendants of its own
- K213497: ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) (2021), 2 descendants of its own
- K223930: A1417MCW/A1717MCW/F1417MCW (2023), 1 descendant of its own
- K241346: IODR1717 / IODR1417 / IODR1417-GF  (Digital Flat Panel X-ray Detector) (2024), 0 descendants of its own
- K182183: GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A (2018), 0 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/K181631
Methodology: https://510kreport.com/methodology