# K200787: BSD3543W

- Pathway: 510(k) (Special)
- Applicant: Bontech Co., Ltd.
- Decided: Apr 23, 2020 after 28 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: 7 generations back to K981556 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162487: BSD3543 Digital Flat Panel X-ray Detector, Bontech, Inc. (2016) Summary page 4.

## Indications for use
The BSD3543W (BT-DA22W/BT-DB22W) detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

Source page: https://510kreport.com/device/K200787
Methodology: https://510kreport.com/methodology