# K093688: Canon, Model Urs-50RF

- Pathway: 510(k) (Traditional)
- Applicant: Virtual Imaging, Inc.
- Decided: Feb 4, 2010 after 66 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: 10 generations back to K890348 (1989). 82 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062623: Axiom Luminos DRF, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K023178: Innova 4100, Ge Medical Systems, Inc. (2002) Summary page 1.
- K091658: GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100, 2100, 3131, 2121, GE Healthcare (2009) Summary page 1.
- K060433: Digital Radiography Cxdi-50C, Canon, Inc. (2006) Summary page 1.
- K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems, Sedecal., Sa. (2009) Summary page 1.
- K092439: Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF, Virtual Imaging, Inc. (2009) Summary page 1.

## Most influential descendants
- K102529: D2RF Digital Dynamic Remote System (2010), 3 descendants of its own
- 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
- K121303: Mobile C-Arm (2012), 0 descendants of its own

## Indications for use
The URS-50RF 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/K093688
Methodology: https://510kreport.com/methodology