# K201591: Flat Panel Detector

- Pathway: 510(k) (Traditional)
- Applicant: Ka Imaging, Inc.
- Decided: Sep 3, 2020 after 83 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.
No later device cites it as a predicate yet.
0 of 20 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.

## Indications for use
The flat panel detector when used with a radiographic imaging system is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes. When the dual energy subtraction function is enabled, it is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures. This device is not intended for use in mammography applications.

Source page: https://510kreport.com/device/K201591
Methodology: https://510kreport.com/methodology