# K162555: Evs 4343, Evs 4343G

- Pathway: 510(k) (Special)
- Applicant: DRTECH Corporation
- Decided: Dec 21, 2016 after 99 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: 9 generations back to K981556 (1998). 19 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142475: EVS 4343, DRTECH Corporation (2015) Summary page 4.
- K150766: Carestream DRX-1 System, Carestream Health, Inc. (2015) Summary page 4.

## Most influential descendants
- K192400: Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG (2019), 6 descendants of its own
- K223124: Expd 86P, Expd 86PG, Expd 129P, Expd 129PG (2022), 2 descendants of its own
- K193031: Expd 4343P, Expd 3643P (2019), 1 descendant of its own
- K242770: Expd 114; Expd 114G; Expd 114P; Expd 114PG (2025), 0 descendants of its own
- K232082: EXPD 4343S (2024), 0 descendants of its own

## Indications for use
The EVS 4343 and EVS 4343G 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/K162555
Methodology: https://510kreport.com/methodology