# K163203: Carestream DRX-Evolution

- Pathway: 510(k) (Special)
- Applicant: Carestream Health, Inc.
- Decided: Dec 13, 2016 after 28 days
- Product code: KPR (System, X-Ray, Stationary)
- 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190330: DRX-Evolution/Plus with Dual Energy (2019), 2 descendants of its own
- K233381: DRX-Evolution Plus System (2024), 1 descendant of its own
- K250954: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K163203
Methodology: https://510kreport.com/methodology