510(k) Report

Devices descending from K232760

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

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