# K122919: Digital Flat Panel X-Ray DETECTOR11417PCA

- Pathway: 510(k) (Traditional)
- Applicant: Rayence Co., Ltd.
- Decided: Jan 1, 2013 after 99 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: 5 generations back to K981556 (1998). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102321: Digital Flat Panel X-Ray Detector Model SDX-4336CP, Samsung Mobile Display Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K130935: Digital Flat Panel X-Ray Detector/1417WCA (2013), 4 descendants of its own
- K171418: 1417WCC_127um and1417WCC_140um (2017), 2 descendants of its own
- K231467: 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF (2023), 1 descendant of its own
- K242394: Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) (2024), 0 descendants of its own
- K141566: Solid State X-Ray Imaging Device, Digiital Flat Panel X-Ray Detector, 1417WCC (2014), 0 descendants of its own

## Indications for use
1417PCA 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/K122919
Methodology: https://510kreport.com/methodology