510(k) Report

Devices descending from K160185

18 later devices reach Wrist 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170978Embrace Neonatal MRI SystemAspect Imaging, Ltd.201717—
+2K254277Embrace Neonatal MRI SystemAspect Imaging, Ltd.20261—
+2K253499Ascent3T Neonatal Magnetic Resonance Imaging SystemEyas Medical Imaging, Inc.20260—
+2K242573NIDO Baby Magnetic Resonance Imaging SystemJiangsu Lici Medical Device Co., Ltd.20240—
+2K192002Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc.202013—
+3K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.20260—
+3K232644neuro42 MRI SystemNeuro42, Inc.20240—
+3K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc.202010—
+4K221923Swoop Portable MR Imaging SystemHyperfine, Inc.20228—
+4K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc.20210—
+5K223247Swoop Portable MR Imaging SystemHyperfine, Inc.20227—
+6K230208Swoop® Portable MR Imaging System™Hyperfine, Inc.20236—
+7K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.20235—
+8K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.20244—
+9K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.20252—
+9K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.20252—
+10K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+11K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—