Swoop® Portable MR Imaging System™

Swoop® Portable MR Imaging System™ is an FDA 510(k)-cleared medical device (K230208) 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 February 21, 2023. Regulation: 8.