# K231467: 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Jun 21, 2023 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: 8 generations back to K981556 (1998). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171418: 1417WCC_127um and1417WCC_140um, Rayence Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K242394: Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) (2024), 0 descendants of its own

## Indications for use
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/K231467
Methodology: https://510kreport.com/methodology