510(k) K033377

FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L by Fujifilm Medical System U.S.A., Inc. — Product Code LMC

K033377 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L". The FDA issued a decision of Substantially Equivalent on January 9, 2004. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.