# K240771: PRORAD X-Ray Flat Panel Detector with DROC

- Pathway: 510(k) (Traditional)
- Applicant: Prognosys Medical Systems Private Limited
- Decided: Nov 12, 2024 after 236 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: 14 generations back to K981556 (1998). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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 5.
- K210988: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2021) Summary page 5.
- K220510: Yushan X-Ray Flat Panel Detector with DROC, Innocare Optoelectronics Corp. (2022) Summary page 6.

## Indications for use
The Wireless(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC)/Wired(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC, W17 Clarity, W17 HC) PRORAD 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 PRORAD X-Ray Flat Panel Detector with DROC 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/K240771
Methodology: https://510kreport.com/methodology