Lucy Point-of-Care Magnetic Resonance Imaging Device

Lucy Point-of-Care Magnetic Resonance Imaging Device is an FDA 510(k)-cleared medical device (K192002) manufactured by Hyperfine Research, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2020. Regulation: 8.