510(k) K051258

KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 by Eastman Kodak Company — Product Code KPR

K051258 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345". The FDA issued a decision of Substantially Equivalent on June 1, 2005. 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.