510(k) K163312

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software by Siemens Medical Solutions USA, Inc. — Product Code LNH

K163312 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software". The FDA issued a decision of Substantially Equivalent on Jan 27, 2017. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.