510(k) Report

Devices descending from K250236

2 later devices reach Swoop® Portable MR Imaging® System (V2) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+2K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—