510(k) K943822

FUJI UM MAMMO SERIES INTENSIFY SCREENS: by Fujifilm Medical System U.S.A., Inc. — Product Code EAM

K943822 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJI UM MAMMO SERIES INTENSIFY SCREENS:". The FDA issued a decision of Substantially Equivalent on August 22, 1994. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.