510(k) K173132

ASPIRE Cristalle by Fujifilm Medical Systems U.S.A, Inc. — Product Code MUE

K173132 is an FDA 510(k) premarket notification submitted by Fujifilm Medical Systems U.S.A, Inc. for the device "ASPIRE Cristalle". The FDA issued a decision of Substantially Equivalent on October 27, 2017. 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 Systems U.S.A, Inc. has at least 10 other 510(k) clearances on record.