510(k) Report

Devices descending from K162376

3 later devices reach CAAS MR 4D Flow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191544Synapse 3D Blood Flow AnalysisFujifilm Corporation20190—
+1K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+2K232007CAAS MR SolutionsPie Medical Imaging BV20240—