# K220510: Yushan X-Ray Flat Panel Detector with DROC

- Pathway: 510(k) (Traditional)
- Applicant: Innocare Optoelectronics Corp.
- Decided: Apr 14, 2022 after 51 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: 13 generations back to K981556 (1998). 20 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 26 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 4.
- K132509: FDR D-Evo Flat Panel Detector System, Fujifilm Medical Systems U.S.A, Inc. (2013) Summary page 5.

## Most influential descendants
- K243171: Yushan X-Ray Flat Panel Detector (2024), 1 descendant of its own
- K223009: Wireless/Wired X-Ray Flat Panel Detectors (2022), 1 descendant of its own
- K250211: Yushan X-Ray Flat Panel Detector (2025), 0 descendants of its own
- K243734: Wireless/ Wired X-Ray Flat Panel Detectors (2025), 0 descendants of its own
- K240771: PRORAD X-Ray Flat Panel Detector with DROC (2024), 0 descendants of its own

## Indications for use
The 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/K220510
Methodology: https://510kreport.com/methodology