510(k) Report

Devices descending from K052839

43 later devices reach CT Perfusion 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193289FastStroke, CT Perfusion 4DGE Medical Systems SCS20201—
+1K151212Ziostation2Qi Imaging, LLC20152—
+1K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+1K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+1K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+1K073238Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions200819—
+1K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+2K251484CT:VQ4Dmedical Limited20250—
+2K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+2K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+2K181892Ziostation2Ziosoft, Inc.20181—
+2K123541Syngo.CT Neuro PerfusionSiemens Medical Systems, Inc.20132—
+2K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+2K121213VitreaadvancedVital Images, Inc.201281
+2K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+2K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+3K220349TeraRecon NeuroTerarecon,Inc.20220—
+3K200315Ziostation2Ziosoft, Inc.20200—
+3K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+3K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+3K163284syngo. CT Neuro PerfusionSiemens Medical Solutions USA, Inc.20171—
+3K153289HealthmyneHealthmyne, Inc.20160—
+3K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+3K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+3K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+4K202213syngo.CT Neuro PerfusionSiemens Medical Solutions USA, Inc.20200—
+4K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K233457RUSHutom, Inc.20240—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—