510(k) Report

Devices descending from K012086

207 later devices reach Aquariusnet Server through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121916IntuitionTerarecon,Inc.201351
+1K081985AW ServerGe Medical Systems, LLC2008275
+1K072205Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc.200736—
+1K062490Visage Pacs/CS, Release Version 4.1Mercury Computer Systems, Inc.20067—
+1K061214Aquariusaps ServerTerarecon,Inc.2006134—
+1K060035MdxnetCybermdx, Inc.20060—
+1K051809Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management SystemMedical Insight A/S20052—
+2K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+2K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+2K200274CariCloudCaristo Diagnostics20200—
+2K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+2K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+2K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+2K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+2K132853NovapacsNovarad Corp.201462
+2K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+2K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+2K113620Myrian 1.11Intrasense20126—
+2K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+2K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+2K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+2K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+2K100619Symbia.Net, Symbia.Net Select Model 10520828, 10520827Siemens Medical Solutions USA, Inc.20101—
+2K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+2K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC20091—
+2K082269Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc.200820—
+2K082430Syngo Imaging XSSiemens AG Medical Solutions20081112
+2K080334InstaradMedsphere Technologies Pvt, Ltd.20082—
+2K073306XoranconnectXoran Technologies, Inc.200801
+2K063392Imco-StatImco Technologies20061—
+3K253927LiveMedica Enterprise PACSLive Medica, LLC20260—
+3K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+3K233660nCommand Lite SystemIonic Health20240—
+3K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+3K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+3K203249Nucleus.ioNucleushealth, LLC202051
+3K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+3K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+3K200899Quantib AI NodeQuantib B.V.20200—
+3K200179Collaboration LivePhilips Health Care20204—
+3K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+3K171130Nucleus Image Management SystemNucleushealth, LLC20170—
+3K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+3K160371NovaPACSNovarad Corporation20165—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K142196Visage Ease ProVisage Imaging GmbH20150—
+3K142647mint LesionMint Medical GmbH201523
+3K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K133357Charruapacs SystemCharruasoft SA20130—
+3K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+3K123920Syngo.ViaSiemens AG Medical Solutions201363—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K120718Instapacs/InstarispacsMeddiff Technologies Pvt., Ltd.20120—
+3K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+3K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+3K112480View 1 ImagingKarl Storz Endoscopy America, Inc.20110—
+3K111319Ibis Explorer and Markup SoftwareMedqia20116—
+3K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+3K093612Syngo.PlazaSiemens AG Medical Solutions20101016
+3K0937033DIShina Systems, Ltd.20102—
+4K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+4K243703TechLiveDeepHealth, Inc.20250—
+4K243333rTOPRoclub GmbH20250—
+4K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+4K241981Change Healthcare Stratus Imaging PACSChange Healthcare Canada Company20240—
+4K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+4K223261Open RibCanon Medical Informatics, Inc.20230—
+4K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+4K220929ExcelsiorMerit Cro, Inc.20220—
+4K220349TeraRecon NeuroTerarecon,Inc.20220—
+4K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+4K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+4K202229AI MetricsAi Metrics, LLC20200—
+4K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+4K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+4K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+4K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+4K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+4K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+4K171754NovaPACSNovarad Corporation201741
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+4K122205EXINIExini Diagnostics AB20125—
+4K1125303DI Including CscoreShina Systems, Ltd.20111—
+4K101666Syngo. Plaza VA20ASiemens AG Medical Solutions201093
+5K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K241546aiCockpit AI ViewerFovia, Inc.20250—
+5K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—