510(k) K191050

MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow by Siemens Medical Solutions USA, Inc. — Product Code LNH

K191050 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow". The FDA issued a decision of Substantially Equivalent on Jul 12, 2019. 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.