510(k) K212873

Aspire Cristalle by Fujifilm Corporation — Product Code MUE

K212873 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "Aspire Cristalle". The FDA issued a decision of Substantially Equivalent on May 27, 2022. 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 Corporation has at least 10 other 510(k) clearances on record.