510(k) Report

Devices descending from K201722

10 later devices reach Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221923Swoop Portable MR Imaging SystemHyperfine, Inc.20228—
+1K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc.20210—
+2K223247Swoop Portable MR Imaging SystemHyperfine, Inc.20227—
+3K230208Swoop® Portable MR Imaging System™Hyperfine, Inc.20236—
+4K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.20235—
+5K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.20244—
+6K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.20252—
+6K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.20252—
+7K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+8K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—