510(k) K153343

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit by Siemens Medi Cal Solutions, Inc. — Product Code LNH

K153343 is an FDA 510(k) premarket notification submitted by Siemens Medi Cal Solutions, Inc. for the device "MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit". The FDA issued a decision of Substantially Equivalent on April 15, 2016. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Medi Cal Solutions, Inc. has at least 10 other 510(k) clearances on record.