510(k) K232535

MAGNETOM Sola; MAGNETOM Altea by Siemens Medical Solutions USA, Inc. — Product Code LNH

K232535 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MAGNETOM Sola; MAGNETOM Altea". The FDA issued a decision of Substantially Equivalent on December 22, 2023. 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 at least 10 other 510(k) clearances on record.