# K220536: Digital flat panel detector

- Pathway: 510(k) (Traditional)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Apr 28, 2022 after 63 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: 1 generation back to K190611 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190611: Vivix-S 1751S, Vieworks Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K230059: Digital Flat Panel Detector (2023), 0 descendants of its own

## Indications for use
The Venul748V flat panel detector is provided as an imaging component to the system manufacturer. It is mainly used in long bones, spine and other inspection fields. After collecting static images, the imaged data is output to the processing equipment. This device is suitable for providing radiography imaging for adult via DR system. The remaining notes depend on the final DR system. [t is not intended for mammography, dental applications, neonatal and fluoroscopy.

Source page: https://510kreport.com/device/K220536
Methodology: https://510kreport.com/methodology