510(k) K242524

SyMRI by Syntheticmr AB (Publ.) — Product Code LNH

K242524 is an FDA 510(k) premarket notification submitted by Syntheticmr AB (Publ.) for the device "SyMRI". The FDA issued a decision of Substantially Equivalent on December 6, 2024. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Syntheticmr AB (Publ.) has at least 1 other 510(k) clearance on record.