510(k) Report

Devices descending from K073138

32 later devices reach Cardiq Express Version 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151212Ziostation2Qi Imaging, LLC20152—
+1K132523MyoperfusionToshibamedical Systems Corporation201311
+1K120910Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 RevealGE Medical Systems SCS20122—
+1K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+1K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+1K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+2K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+2K183161SnapShot Freeze 2Ge Medical Systems, LLC20190—
+2K181892Ziostation2Ziosoft, Inc.20181—
+2K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+2K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+2K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+2K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+2K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+3K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+3K200315Ziostation2Ziosoft, Inc.20200—
+3K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+3K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+4K220349TeraRecon NeuroTerarecon,Inc.20220—
+4K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+4K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K241440HealthCCSngNano-X AI, Ltd.20240—
+5K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K230112CAC SoftwareImbio, Inc.20230—
+5K230223iCAC DeviceBunkerhill, Inc.20236—
+6K260166Bunkerhill Contrast CACBunkerHill Health20260—
+6K250662Bunkerhill MACBunkerHill Health20250—
+6K243229Bunkerhill AVCBunkerHill Health20253—
+6K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—