Swoop® Portable MR Imaging® System

Swoop® Portable MR Imaging® System is an FDA 510(k)-cleared medical device (K240944) 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 15, 2024. Regulation: 8.