510(k) K252379

AIR Recon DL by Ge Medical Systems, LLC — Product Code LNH

K252379 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "AIR Recon DL". The FDA issued a decision of Substantially Equivalent on December 23, 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.