510(k) K251386

ECHELON Synergy by Fujifilm Corporation — Product Code LNH

K251386 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "ECHELON Synergy". The FDA issued a decision of Substantially Equivalent on September 17, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Fujifilm Corporation has at least 10 other 510(k) clearances on record.