# K232753: Expd 4343D; Expd 3643D

- Pathway: 510(k) (Special)
- Applicant: DRTECH Corporation
- Decided: Nov 16, 2023 after 69 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.
No later device cites it as a predicate yet.
0 of 22 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.

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

Source page: https://510kreport.com/device/K232753
Methodology: https://510kreport.com/methodology