Cleared Traditional

K093478 - KODAK RVG 6500 SYSTEM AND KODAK RVG 650...

K093478 is the FDA 510(k) clearance for KODAK RVG 6500 SYSTEM AND KODAK RVG 650... by Trophy. It is a Class 2 Radiology device (product code MUH) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K093478 · Trophy · Radiology device
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Apr 2010
Decision
168d
Days
Class 2
Risk

K093478 is an FDA 510(k) clearance for the KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Trophy (Croissy-Beaubourg, FR). The FDA issued a Cleared decision on April 26, 2010 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trophy devices

Submission Details

510(k) Number K093478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2009
Decision Date April 26, 2010
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - MUH System, X-ray, Extraoral Source, Digital

All 72
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