510(k) Report

Devices descending from K170978

17 later devices reach Embrace Neonatal MRI System through their predicates, nearest generation first.

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