# K201796: 1717SCV, 1717SGV

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Jul 23, 2020 after 23 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.
- K171419: 1717SGC_127um and 1717SGC_140um, Rayence Co., Ltd. (2017) Summary page 5.

## Indications for use
1717SCV and 1717SGV X-ray detectors, 127um and 140um, are 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/K201796
Methodology: https://510kreport.com/methodology
