Cleared Traditional

CANON, MODEL URS-50RF

K093688 · Virtual Imaging, Inc. · Radiology

Feb 2010

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K093688 is an FDA 510(k) clearance for the CANON, MODEL URS-50RF, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Virtual Imaging, Inc. (Naples, US). The FDA issued a Cleared decision on February 4, 2010, 66 days after receiving the submission on November 30, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K093688 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2009
Decision Date	February 04, 2010
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy