# K191504: PowerDR

- Pathway: 510(k) (Traditional)
- Applicant: Radiology Information Systems, Inc.
- Decided: Aug 16, 2019 after 71 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K803130 (1981). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130318: Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB), Varian Medical Systems, X-Ray Products-Infimed (2013) Summary page 4.

## Indications for use
The PowerDR Digital X-ray Imaging System is indicated for use as an X-ray imaging modality to acquire, process, display, quality assure and store digital medical X-ray images. The PowerDR Digital X-ray Imaging System is indicated for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not indicated for use in mammography.

Source page: https://510kreport.com/device/K191504
Methodology: https://510kreport.com/methodology