# K230059: Digital Flat Panel Detector

- Pathway: 510(k) (Special)
- Applicant: Ray Imaging Technology (Haining) Limited
- Decided: Feb 3, 2023 after 25 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: 2 generations back to K190611 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220536: Digital flat panel detector, Iray Technology Taicang, Ltd. (2022) Summary page 7.

## Indications for use
Venul748V and DRX-LC, as a major imaging component, are supplied to the manufacturers of medical diagnostic X-ray photography systems, and used in conjunction with the medical diagnostic X-ray photography system to image the object to be checked. They are capable of outputting the acquired static images to a processing device after acquisition.

Source page: https://510kreport.com/device/K230059
Methodology: https://510kreport.com/methodology