510(k) Report

Devices descending from K140587

19 later devices reach MR-CT Vva through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+1K191125ADAS 3DGalgo Medical S.L20205—
+1K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+1K181892Ziostation2Ziosoft, Inc.20181—
+1K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+1K163253Arterys Cardio DLArterys, Inc.20174—
+1K162513Arterys Software v2.0Arterys, Inc.20165—
+1K162112Caas MRVPie Medical Imaging BV20162—
+2K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+2K210850ADAS 3DAdas3D Medical S.L.20214—
+2K200315Ziostation2Ziosoft, Inc.20200—
+2K182034Arterys MICAArterys, Inc.20183—
+3K212421ADAS 3DAdas3D Medical S.L.20213—
+3K192437Arterys MICAArterys, Inc.20202—
+4K230803ADAS 3DAdas3D Medical S.L.20232—
+4K203744Arterys MICAArterys, Inc.20221—
+5K252539Tempus PixelArterys, Inc.20250—
+5K240791ADAS 3DAdas3D Medical S.L.20241—
+6K253969ADAS 3DAdas3D Medical S.L.20260—