# K243734: Wireless/ Wired X-Ray Flat Panel Detectors

- Pathway: 510(k) (Special)
- Applicant: Allengers Medical Systems Limited
- Decided: Apr 18, 2025 after 135 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: 15 generations back to K981556 (1998). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223009: Wireless/Wired X-Ray Flat Panel Detectors, Allengers Medical Systems Limited (2022) Summary page 5.

## 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/screener CR system is used. Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.

Source page: https://510kreport.com/device/K243734
Methodology: https://510kreport.com/methodology