510(k) Report

Devices descending from K001773

24 later devices reach Orthone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120701M2 Wrist Mri SystemAspect Imaging, Ltd.201320—
+1K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc.200823
+2K130692M2 Wrist 2 Mri SystemAspect Imaging, Ltd.201419—
+2K1032381.5T Optima MR430SGe Medical Systems, LLC201112
+3K160185Wrist 3Aspect Imaging, Ltd.201618—
+3K123068Optima MR 430SGe Medical Systems, LLC201202
+4K170978Embrace Neonatal MRI SystemAspect Imaging, Ltd.201717—
+5K254277Embrace Neonatal MRI SystemAspect Imaging, Ltd.20261—
+5K253499Ascent3T Neonatal Magnetic Resonance Imaging SystemEyas Medical Imaging, Inc.20260—
+5K242573NIDO Baby Magnetic Resonance Imaging SystemJiangsu Lici Medical Device Co., Ltd.20240—
+5K192002Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc.202013—
+6K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.20260—
+6K232644neuro42 MRI SystemNeuro42, Inc.20240—
+6K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc.202010—
+7K221923Swoop Portable MR Imaging SystemHyperfine, Inc.20228—
+7K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc.20210—
+8K223247Swoop Portable MR Imaging SystemHyperfine, Inc.20227—
+9K230208Swoop® Portable MR Imaging System™Hyperfine, Inc.20236—
+10K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.20235—
+11K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.20244—
+12K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.20252—
+12K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.20252—
+13K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.20251—
+14K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.20260—