# K232082: EXPD 4343S

- Pathway: 510(k) (Special)
- Applicant: DRTECH Corporation
- Decided: Feb 13, 2024 after 215 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). 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)
- K193031: Expd 4343P, Expd 3643P, DRTECH Corporation (2019) Summary page 4.

## Indications for use
The EXPD 4343S Digital X-ray detector is indicated for use in generating radiographic images of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures on general populations. This device is not intended for mammography applications.

Source page: https://510kreport.com/device/K232082
Methodology: https://510kreport.com/methodology