510(k) K253678

MAMMOMAT B.brilliant (11372950) by Siemens Medical Solutions USA, Inc. — Product Code MUE

K253678 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MAMMOMAT B.brilliant (11372950)". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.