510(k) Report

Devices descending from K212456

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221393Swoop Portable MR Imaging SystemHyperfine, Inc.20229—
+2K221923Swoop Portable MR Imaging SystemHyperfine, Inc.20228—
+3K223247Swoop Portable MR Imaging SystemHyperfine, Inc.20227—
+4K230208Swoop® Portable MR Imaging System™Hyperfine, Inc.20236—
+5K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.20235—
+6K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.20244—
+7K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.20252—
+7K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.20252—
+8K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+9K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—