510(k) Report

Devices descending from K012072

219 later devices reach Voxar VC, Model 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040126Viatronix V3D Colon, Revision 1.3Viatronix, Inc.20042—
+1K033102Medic Colon Model, Release 1Medicsight2003210—
+1K020658Viatronix V3D ColonViatronix, Inc.20024—
+2K123566Synapse 3D Colon AnalysisFujifilm Medical Systems U.S.A, Inc.20130—
+2K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+2K042674Colon Car 1.2Medicsight2004209—
+2K023943CT ColonographyGe Medical Systems, Inc.20033—
+3K083423Coloncad Api 3.1Medicsight Plc201170—
+3K091529Icad Veralook CTC Cad SoftwareIcad, Inc.20102—
+3K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation20090—
+3K061214Aquariusaps ServerTerarecon,Inc.2006134—
+3K041270CT Colonography IIGeneral Electric Medical Systems20042—
+4K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+4K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+4K173744ProFuse CADEigen20181—
+4K132853NovapacsNovarad Corp.201462
+4K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+4K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+4K121916IntuitionTerarecon,Inc.201351
+4K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+4K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K200274CariCloudCaristo Diagnostics20200—
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K160371NovaPACSNovarad Corporation20165—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+5K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K223261Open RibCanon Medical Informatics, Inc.20230—
+6K220349TeraRecon NeuroTerarecon,Inc.20220—
+6K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+6K203555AmCAD-UTAmcad Biomed Corporation20212—
+6K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+6K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+6K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+6K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+6K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+6K171754NovaPACSNovarad Corporation201741
+6K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+7K231662Aid-UIaid20241—
+7K223424Spine Auto ViewsGE Medical Systems SCS20230—
+7K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K250039HPACSHealthhub20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K250484PIUR tUS insidePiur Imaging GmbH20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I