510(k) K202014

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit by Siemens Medical Solutions USA, Inc. — Product Code LNH

K202014 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit". The FDA issued a decision of Substantially Equivalent on Sep 8, 2020. 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.