510(k) K253808

AIR Recon DL by GE Medical Systems — Product Code LNH

K253808 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "AIR Recon DL". The FDA issued a decision of Substantially Equivalent on August 13, 2026. 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 has at least 10 other 510(k) clearances on record.