510(k) K122454

FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION by Fujifilm Medical System U.S.A., Inc. — Product Code KPR

K122454 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION". The FDA issued a decision of Substantially Equivalent on November 20, 2012. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.