# K102529: D2RF Digital Dynamic Remote System

- Pathway: 510(k) (Traditional)
- Applicant: Stephanix Radiological Systems
- Decided: Oct 7, 2010 after 35 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K890348 (1989). 83 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093688: Canon, Model Urs-50RF, Virtual Imaging, Inc. (2010) Summary page 1.
- (no number) Virtual Imaging: named in the summary without a submission number

## Most influential descendants
- K213479: D²RS and D²RS 9090 (2021), 1 descendant of its own
- K221335: D²RS and D²RS 9090 (2022), 0 descendants of its own
- K150306: D2RS_AT Digital Dynamic Remote System (2015), 0 descendants of its own

## Recalls of this device
- Nov 2, 2018 · Class II · Z-0557-2019: The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.

## Indications for use
The D'RF 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, diagnastic, and interventional procedures. 1t is Intended to replace fluoroscepic images obtained through image intensifier technology. Not intended for mammography applications.

Source page: https://510kreport.com/device/K102529
Methodology: https://510kreport.com/methodology