# K250211: Yushan X-Ray Flat Panel Detector

- Pathway: 510(k) (Traditional)
- Applicant: Innocare Optoelectronics Corp.
- Decided: Jul 22, 2025 after 179 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)
- K243171: Yushan X-Ray Flat Panel Detector, Innocare Optoelectronics Corp. (2024) Summary page 5.
- K201528: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2020) Summary page 6.
- K210988: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2021) Summary page 6.
- K220510: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2022) Summary page 6.

## Indications for use
The Wireless and Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.

Source page: https://510kreport.com/device/K250211
Methodology: https://510kreport.com/methodology