GeneralDevices & AI clearances

FDA clears Hyperfine's Swoop portable MRI system

U.S. FDA2w ago

FDA clears the Swoop Portable MR Imaging System (Hyperfine) via 510(k) pathway. The system is classified under product code LNH (Radiology).

  • The clearance was issued under the FDA 510(k) pathway.
  • The device is classified as product code LNH (Radiology).
  • Manufacturer: Hyperfine, Inc.
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