# K213479: D²RS and D²RS 9090

- Pathway: 510(k) (Traditional)
- Applicant: Stephanix
- Decided: Dec 23, 2021 after 55 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 86 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.

## Most influential descendants
- K221335: D²RS and D²RS 9090 (2022), 0 descendants of its own

## Indications for use
D2RS & D2RS9090 Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Source page: https://510kreport.com/device/K213479
Methodology: https://510kreport.com/methodology