510(k) K121499

FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM by Fujifilm Medical System U.S.A., Inc. — Product Code IZF

K121499 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 20, 2012. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.