# K162552: Evs 3643, Evs 3643G

- Pathway: 510(k) (Special)
- Applicant: DRTECH Corporation
- Decided: Dec 2, 2016 after 80 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: 10 generations back to K981556 (1998). 20 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151942: EVS 3643, DRTECH Corporation (2015) Summary page 4.
- K150766: Carestream DRX-1 System, Carestream Health, Inc. (2015) Summary page 4.

## Most influential descendants
- K193017: Evs 4343W / Evs 4343WG / Evs 4343WP / Evs 3643W / Evs 3643WG / Evs 3643WP (2019), 1 descendant of its own
- K243443: Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N; Expd 3643U1; Expd 3643NU; Expd 3643NP (2025), 0 descendants of its own
- K171137: Evs 2430W, Evs 2430GW (2017), 0 descendants of its own

## Indications for use
The EVS 3643 and EVS 3643G 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/K162552
Methodology: https://510kreport.com/methodology