510(k) K162102

MAGNETOM Avantofit, MAGNETOM Skyrafit by Siemens Medi Cal Solutions, Inc. — Product Code LNH

K162102 is an FDA 510(k) premarket notification submitted by Siemens Medi Cal Solutions, Inc. for the device "MAGNETOM Avantofit, MAGNETOM Skyrafit". The FDA issued a decision of Substantially Equivalent on November 22, 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.