Cleared Traditional

CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF

K092439 · Virtual Imaging, Inc. · Radiology

Nov 2009

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K092439 is an FDA 510(k) clearance for the CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Virtual Imaging, Inc. (Deerfield, US). The FDA issued a Cleared decision on November 30, 2009, 112 days after receiving the submission on August 10, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K092439 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 2009
Decision Date	November 30, 2009
Days to Decision	112 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