510(k) Report

Devices descending from K133937

10 later devices reach Heartscan Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162376CAAS MR 4D FlowPie Medical Imaging BV20163—
+1K162513Arterys Software v2.0Arterys, Inc.20165—
+2K191544Synapse 3D Blood Flow AnalysisFujifilm Corporation20190—
+2K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+2K163253Arterys Cardio DLArterys, Inc.20174—
+3K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+3K182034Arterys MICAArterys, Inc.20183—
+4K192437Arterys MICAArterys, Inc.20202—
+5K203744Arterys MICAArterys, Inc.20221—
+6K252539Tempus PixelArterys, Inc.20250—