510(k) K210151

Digimamo D by Vmi Tecnologias Ltda — Product Code MUE

K210151 is an FDA 510(k) premarket notification submitted by Vmi Tecnologias Ltda for the device "Digimamo D". The FDA issued a decision of Substantially Equivalent on March 1, 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. Vmi Tecnologias Ltda has at least 2 other 510(k) clearances on record.