510(k) K261283

APERTO Lucent MRI System by Fujifilm Corporation — Product Code LNH

K261283 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "APERTO Lucent MRI System". The FDA issued a decision of Substantially Equivalent on September 16, 2026. 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.