Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is an FDA 510(k)-cleared medical device (K211818) manufactured by Hyperfine, 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 July 6, 2021. Regulation: 8.