Swoop® Portable MR Imaging® System (V2)

Swoop® Portable MR Imaging® System (V2) is an FDA 510(k)-cleared medical device (K250236) 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 May 29, 2025. Regulation: 8.