Cleared Special

K080889 - KODAK 9000C EXTRAORAL IMAGING SYSTEM

K080889 is an FDA 510(k) clearance for KODAK 9000C EXTRAORAL IMAGING SYSTEM, manufactured by Trophy. The device is a Class 2 Radiology device with product code MUH cleared through the Special 510(k) pathway after a 29-day FDA review.

K080889 · Trophy · Radiology device
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Apr 2008
Decision
29d
Days
Class 2
Risk

K080889 is an FDA 510(k) clearance for the KODAK 9000C EXTRAORAL IMAGING 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 29, 2008 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Trophy devices

FDA 510(k) Submission Details - K080889

510(k) Number K080889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date April 29, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MUH Device Classification - Class 2, Special Controls

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 154
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