510(k) Report

Devices descending from K130692

19 later devices reach M2 Wrist 2 Mri System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160185Wrist 3Aspect Imaging, Ltd.201618—
+2K170978Embrace Neonatal MRI SystemAspect Imaging, Ltd.201717—
+3K254277Embrace Neonatal MRI SystemAspect Imaging, Ltd.20261—
+3K253499Ascent3T Neonatal Magnetic Resonance Imaging SystemEyas Medical Imaging, Inc.20260—
+3K242573NIDO Baby Magnetic Resonance Imaging SystemJiangsu Lici Medical Device Co., Ltd.20240—
+3K192002Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc.202013—
+4K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.20260—
+4K232644neuro42 MRI SystemNeuro42, Inc.20240—
+4K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc.202010—
+5K221923Swoop Portable MR Imaging SystemHyperfine, Inc.20228—
+5K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc.20210—
+6K223247Swoop Portable MR Imaging SystemHyperfine, Inc.20227—
+7K230208Swoop® Portable MR Imaging System™Hyperfine, Inc.20236—
+8K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.20235—
+9K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.20244—
+10K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.20252—
+10K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.20252—
+11K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+12K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—