510(k) K093478

KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM by Trophy — Product Code MUH

K093478 is an FDA 510(k) premarket notification submitted by Trophy for the device "KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 2010. 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.