# K141563: Solid State X-Ray Imaging Device, Digital Flat Panel X-Ray Detector, 1417WGC

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Jul 16, 2014 after 34 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 K981556 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131114: Digital Flat Panel X-Ray Detector, Rayence Co., Ltd. (2013) Summary page 2.

## Indications for use
I4I7WGC Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

Source page: https://510kreport.com/device/K141563
Methodology: https://510kreport.com/methodology