510(k) K163252

Mammomat Fusion with Stereotactic Biopsy by Siemens Medical Solutions USA, Inc. — Product Code MUE

K163252 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Mammomat Fusion with Stereotactic Biopsy". The FDA issued a decision of Substantially Equivalent on Jan 10, 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. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.