510(k) K253489

Swoop® Portable MR Imaging® System by Hyperfine, Inc. — Product Code LNH

K253489 is an FDA 510(k) premarket notification submitted by Hyperfine, Inc. for the device "Swoop® Portable MR Imaging® System". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Hyperfine, Inc. has at least 10 other 510(k) clearances on record.