510(k) K951373

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ by Fujifilm Medical System U.S.A., Inc. — Product Code IXW

K951373 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ". The FDA issued a decision of Substantially Equivalent on October 27, 1995. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.