Cleared Traditional

K083725 - RADPRO ION

K083725 is an FDA 510(k) clearance for RADPRO ION, manufactured by Virtual Imaging, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K083725 · Virtual Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
38d
Days
Class 2
Risk

K083725 is an FDA 510(k) clearance for the RADPRO ION. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Virtual Imaging, Inc. (Deer Field, US). The FDA issued a Cleared decision on January 22, 2009 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K083725

510(k) Number K083725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 324
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K083725.
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K080847 · Almana Medical Imaging · Aug 2008
K083725 · RADPRO ION
Download PDF FDA Summary Virtual Imaging, Inc.