510(k) K250379

SIGNA Prime Elite by Ge Medical Systems, LLC — Product Code LNH

K250379 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "SIGNA Prime Elite". The FDA issued a decision of Substantially Equivalent on March 17, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Medical Systems, LLC has at least 10 other 510(k) clearances on record.