510(k) K021829

MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM by Eastman Kodak Company — Product Code MQB

K021829 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 2002. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Eastman Kodak Company has at least 10 other 510(k) clearances on record.