# K201528: Yushan X-Ray Flat Panel Detector with DROC

- Pathway: 510(k) (Traditional)
- Applicant: Innocare Optoelectronics Corp.
- Decided: Oct 11, 2020 after 125 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: 12 generations back to K981556 (1998). 19 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191939: Yushan X-Ray Flat Panel Detector, Innocare Optoelectronics Corp. (2019) Summary page 4.

## Most influential descendants
- K220510: Yushan X-Ray Flat Panel Detector with DROC (2022), 5 descendants of its own
- K210988: Yushan X-Ray Flat Panel Detector with DROC (2021), 5 descendants of its own
- 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

## Indications for use
The Wireless (V14C, V14G, V17C, V17G)/Wired (V14C, V14G, V17C, V17G, V17Ge) Yushan X-Ray Flat Panel Detector with DROC 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 with DROC is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Source page: https://510kreport.com/device/K201528
Methodology: https://510kreport.com/methodology