Cleared Traditional

FLUOROPRO RF DIGITAL IMAGING SYSTEM

K070390 · Virtual Imaging, Inc. · Radiology
Apr 2007
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K070390 is an FDA 510(k) clearance for the FLUOROPRO RF DIGITAL IMAGING SYSTEM, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Virtual Imaging, Inc. (Deer Field, US). The FDA issued a Cleared decision on April 5, 2007, 55 days after receiving the submission on February 9, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K070390 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2007
Decision Date April 05, 2007
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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