510(k) K051483

KODAK DIRECTVIEW DR SYSTEM DETECTOR by Eastman Kodak Company — Product Code MQB

K051483 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DIRECTVIEW DR SYSTEM DETECTOR". The FDA issued a decision of Substantially Equivalent on June 21, 2005. 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.