510(k) K200424

Giotto Class (Models - 3000X-YY and 4000X-YY) by Ims Giotto S.P.A. — Product Code MUE

K200424 is an FDA 510(k) premarket notification submitted by Ims Giotto S.P.A. for the device "Giotto Class (Models - 3000X-YY and 4000X-YY)". The FDA issued a decision of Substantially Equivalent on June 18, 2020. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Ims Giotto S.P.A. has at least 1 other 510(k) clearance on record.