# K190330: DRX-Evolution/Plus with Dual Energy

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Nov 4, 2019 after 263 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
Longest line of descent: 5 generations back to K862120 (1986). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163203: Carestream DRX-Evolution, Carestream Health, Inc. (2016) Summary page 4.
- K013481: Dual Energy and Tissue Equalization Software Option, GE Medical Systems (2001) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. This device also supports dual energy chest imaging. The tomography and dual energy features are not to be used for imaging pediatric patients.

Source page: https://510kreport.com/device/K190330
Methodology: https://510kreport.com/methodology