510(k) Report

Devices descending from K240944

4 later devices reach Swoop® Portable MR Imaging® System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.20252—
+1K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.20252—
+2K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+3K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—