510(k) Report

Devices descending from K230208

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.20235—
+2K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.20244—
+3K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.20252—
+3K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.20252—
+4K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+5K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—