510(k) K080889

KODAK 9000C EXTRAORAL IMAGING SYSTEM by Trophy — Product Code MUH

K080889 is an FDA 510(k) premarket notification submitted by Trophy for the device "KODAK 9000C EXTRAORAL IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 2008. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Trophy has at least 10 other 510(k) clearances on record.