510(k) K212456

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System by Hyperfine, Inc. — Product Code LNH

K212456 is an FDA 510(k) premarket notification submitted by Hyperfine, Inc. for the device "Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System". The FDA issued a decision of Substantially Equivalent on November 17, 2021. 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.