# K171085: GMR40

- Pathway: 510(k) (Traditional)
- Applicant: Neurologica Corporation, A Subsidiary OF
- Decided: May 11, 2017 after 29 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K862120 (1986). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153401: GR40CW, Samsung Electronics Co., Ltd. (2015) Summary page 7.

## Recalls of this device
- Jan 12, 2018 · Class II · Z-1391-2018: While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

## Indications for use
The GMR40 Digital X-ray Imaging System is intended for use with portable radiographic applications wherever conventional screen-film systems or computed radiography (CR) may be used. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K171085
Methodology: https://510kreport.com/methodology