510(k) Report

Devices descending from K192002

13 later devices reach Lucy Point-of-Care Magnetic Resonance Imaging Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242573NIDO Baby Magnetic Resonance Imaging SystemJiangsu Lici Medical Device Co., Ltd.20240—
+1K232644neuro42 MRI SystemNeuro42, Inc.20240—
+1K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc.202010—
+2K221923Swoop Portable MR Imaging SystemHyperfine, Inc.20228—
+2K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc.20210—
+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—