Swoop® Portable MR Imaging System®

Swoop® Portable MR Imaging System® is an FDA 510(k)-cleared medical device (K232760) 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 October 5, 2023. Regulation: 8.