# K231959: Expd 4357; Expd 4357P

- Pathway: 510(k) (Special)
- Applicant: DRTECH Corporation
- Decided: Aug 1, 2023 after 29 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)
- K223124: Expd 86P, Expd 86PG, Expd 129P, Expd 129PG, DRTECH Corporation (2022) Summary page 4.

## Indications for use
The EXPD 4357, EXPD 4357P 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/K231959
Methodology: https://510kreport.com/methodology