510(k) K173408

Mammomat Revelation by Siemens Medi Cal Solutions, Inc. — Product Code MUE

K173408 is an FDA 510(k) premarket notification submitted by Siemens Medi Cal Solutions, Inc. for the device "Mammomat Revelation". The FDA issued a decision of Substantially Equivalent on March 21, 2018. 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 Medi Cal Solutions, Inc. has at least 10 other 510(k) clearances on record.