# K193031: Expd 4343P, Expd 3643P

- Pathway: 510(k) (Special)
- Applicant: DRTECH Corporation
- Decided: Nov 22, 2019 after 23 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). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192400: Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG, DRTECH Corporation (2019) Summary page 4.

## Most influential descendants
- K232082: EXPD 4343S (2024), 0 descendants of its own

## Indications for use
The EXPD 4343P / EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Source page: https://510kreport.com/device/K193031
Methodology: https://510kreport.com/methodology