510(k) K002146

KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY by Eastman Kodak Company — Product Code LMC

K002146 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY". The FDA issued a decision of Substantially Equivalent on September 27, 2000. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Eastman Kodak Company has at least 10 other 510(k) clearances on record.