510(k) Report

Devices descending from K953616

230 later devices reach Preview Surgery Planning Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040852Preview Treatment Planning SoftwareMedical Media Systems, Inc.2004229—
+2K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+2K051528Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG2005226—
+3K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+3K142048Emprint Procedure Planning ApplicationCovidien, LLC20143—
+3K131498Iqqa-Liver Multimodality SoftwareEdda Technology, Inc.201316—
+3K121213VitreaadvancedVital Images, Inc.201281
+3K082228Planisight LinasysPathfinder Therapeutics, Inc.200823—
+3K061696Iqqa-Liver SoftwareEdda Technology, Inc.2006217—
+3K060453Aze VirtualplaceAze, Ltd.20061—
+4K241543DrAid™ for Liver SegmentationVinbrain Joint Stock Company20240—
+4K231690iCAS-LVHighrad, Ltd.20240—
+4K183133MRCP+ v1.0Perspectum Diagnostics, Ltd.20191—
+4K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+4K180192Emprint Ablation Visualization ApplicationCovidien, LLC20182—
+4K153289HealthmyneHealthmyne, Inc.20160—
+4K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+4K133643Syngo, CT Liver AnalysisSiemens Medi Cal Solutions, Inc.20141—
+4K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K121916IntuitionTerarecon,Inc.201351
+4K113620Myrian 1.11Intrasense20126—
+4K110186Synapse 3D Liver AnalysisFujifilm Medical System U.S.A., Inc.20113—
+4K091001Myrian 1.4Intrasense20097—
+4K071310Syngo CT Oncology Software PackageSiemens AG2007195—
+5K240620Cube NavigatorMedical Templates AG20240—
+5K233930MRCP+ version 2 (MRCP+ v2)Perspectum20240—
+5K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+5K200274CariCloudCaristo Diagnostics20200—
+5K192038Emprint Visualization ApplicationCovidien, LLC20191—
+5K191530StoneCheckerImaging Biometrics, LLC20191—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K180867AmCAD-UOAmcad Biomed Corporation20180—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K120484Visia OncologyMeVis Medical Solutions AG20128—
+5K113541Clearstart SVM SystemIntio, Inc.201171
+5K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+5K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+6K252947HistoSonics® Planning ToolHistoSonics, Inc.20260—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K202084DeepLook PRECISEDeeplook, Inc.20210—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+6K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+6K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+6K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+6K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+6K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K233457RUSHutom, Inc.20240—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+7K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+7K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+7K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+7K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+7K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K123920Syngo.ViaSiemens AG Medical Solutions201363—
+7K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+7K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—