510(k) Report

Devices descending from K200973

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

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