# K191879: DRX-Evolution with Carestream Digital Tomosynthesis

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Dec 20, 2019 after 158 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: 4 generations back to K020635 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141837: DRX-Evolution, Carestream Health, Inc. (2015) Summary page 4.

## 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 digital tomosynthesis. The tomography and digital tomosynthesis features are not to be used for imaging pediatric patients.

Source page: https://510kreport.com/device/K191879
Methodology: https://510kreport.com/methodology