# K210985: 1717FCC

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Apr 28, 2021 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: 10 generations back to K803130 (1981). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171420: 1717SCC_127um and 1717SCC_140um, Rayence Co., Ltd. (2017) Summary page 4.
- K171461: SkyPlate Detector for Philips Radiography/Fluoroscopy Systems, Philips Medical Systems Dmc GmbH (2017) Summary page 10.

## Indications for use
1717FCC 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/K210985
Methodology: https://510kreport.com/methodology