510(k) K260852

MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure by Siemens Healthineers AG — Product Code LNH

K260852 is an FDA 510(k) premarket notification submitted by Siemens Healthineers AG for the device "MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Healthineers AG has at least 6 other 510(k) clearances on record.