Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is an FDA 510(k)-cleared medical device (K201722) 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 August 10, 2020. Regulation: 8.