510(k) K121674

ASPIRE HD PLUS, ASPIRE HD-S by Fujifilm Medical System U.S.A., Inc. — Product Code MUE

K121674 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "ASPIRE HD PLUS, ASPIRE HD-S". The FDA issued a decision of Substantially Equivalent on September 21, 2012. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.