# K160204: BSD4343 Digital Flat Panel X-ray Detector

- Pathway: 510(k) (Traditional)
- Applicant: Bontech, Inc.
- Decided: Jun 9, 2016 after 133 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: 5 generations back to K981556 (1998). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102587: LLX240AB01, Samsung Mobile Display Co., Ltd. (2010) Summary page 5.

## Most influential descendants
- K162487: BSD3543 Digital Flat Panel X-ray Detector (2016), 1 descendant of its own
- K200787: BSD3543W (2020), 0 descendants of its own

## Indications for use
The BSD4343 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/K160204
Methodology: https://510kreport.com/methodology