510(k) K221393

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

K221393 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 June 10, 2022. 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.