# K223687: X-ray Flat Panel Detectors (EverestView 4343X)

- Pathway: 510(k) (Special)
- Applicant: Careray Digital Medical Technology Co., Ltd.
- Decided: Dec 30, 2022 after 21 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 K803130 (1981). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221549: X-ray Flat Panel Detectors (CareView 1800 RF), Careray Digital Medical Technology Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- K232058: YosemiteView 4343W/YosemiteView 3643W (2023), 0 descendants of its own

## Indications for use
The 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/K223687
Methodology: https://510kreport.com/methodology