# K223009: Wireless/Wired X-Ray Flat Panel Detectors

- Pathway: 510(k) (Traditional)
- Applicant: Allengers Medical Systems Limited
- Decided: Nov 27, 2022 after 59 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: 14 generations back to K981556 (1998). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201528: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2020) Summary page 5.
- K210988: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2021) Summary page 5.
- K220510: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2022) Summary page 5.

## Most influential descendants
- K243734: Wireless/ Wired X-Ray Flat Panel Detectors (2025), 0 descendants of its own

## Indications for use
Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.

Source page: https://510kreport.com/device/K223009
Methodology: https://510kreport.com/methodology