# K150306: D2RS_AT Digital Dynamic Remote System

- Pathway: 510(k) (Traditional)
- Applicant: Stephanix Radiological Solutions
- Decided: Oct 10, 2015 after 243 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: 12 generations back to K890348 (1989). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102529: D2RF Digital Dynamic Remote System, Stephanix Radiological Systems (2010) Summary page 4.

## Indications for use
The D’RS_AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It Is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Source page: https://510kreport.com/device/K150306
Methodology: https://510kreport.com/methodology