510(k) K060550

KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 by Eastman Kodak Company — Product Code KPR

K060550 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386". The FDA issued a decision of Substantially Equivalent on March 31, 2006. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Eastman Kodak Company has at least 10 other 510(k) clearances on record.