510(k) Report

Devices descending from K130383

5 later devices reach Synapse 3D Cardiac Tools through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+2K220039AutoSegAi Medic, Inc.20221—
+2K220727inHEART MODELSInheart, Sas20221—
+3K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+3K231683inHEART ModelsInheart, Sas20240—