Cleared Traditional

RADPRO ION

K083725 · Virtual Imaging, Inc. · Radiology

Jan 2009

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K083725 is an FDA 510(k) clearance for the RADPRO ION, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Virtual Imaging, Inc. (Deer Field, US). The FDA issued a Cleared decision on January 22, 2009, 38 days after receiving the submission on December 15, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K083725 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2008
Decision Date	January 22, 2009
Days to Decision	38 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