# K202995: X-ray Flat Panel Detectors/CareView 3600RF

- Pathway: 510(k) (Traditional)
- Applicant: Careray Digital Medical System Co., Ltd.
- Decided: Feb 19, 2021 after 141 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: 11 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)
- K161730: Wireless Digital Flat Panel Detector, Iray Technology (Shanghai), Ltd. (2016) Summary page 6.

## Indications for use
The CareView 3600RF detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.

Source page: https://510kreport.com/device/K202995
Methodology: https://510kreport.com/methodology