510(k) Report

Devices descending from K110366

25 later devices reach Syngo.CT Cardiac Function through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+1K132523MyoperfusionToshibamedical Systems Corporation201311
+1K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+1K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+2K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+2K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+2K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+2K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+3K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+3K220349TeraRecon NeuroTerarecon,Inc.20220—
+3K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+3K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+3K181892Ziostation2Ziosoft, Inc.20181—
+4K241440HealthCCSngNano-X AI, Ltd.20240—
+4K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+4K230112CAC SoftwareImbio, Inc.20230—
+4K230223iCAC DeviceBunkerhill, Inc.20236—
+4K200315Ziostation2Ziosoft, Inc.20200—
+5K260166Bunkerhill Contrast CACBunkerHill Health20260—
+5K250662Bunkerhill MACBunkerHill Health20250—
+5K243229Bunkerhill AVCBunkerHill Health20253—
+5K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+6K260167Bunkerhill Contrast AVCBunkerHill Health20260—