510(k) Report

Devices descending from K012313

580 later devices reach CT Colonography/NAVIGATOR2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K182966PLANET Onco DoseDosisoft20191—
+4K182855ProKnow DSProknow, LLC20192—
+4K173744ProFuse CADEigen20181—
+4K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+4K181572Workflow BoxMirada Medical, Ltd.201825—
+4K171350Collision CheckRadformation, Inc.20174—
+4K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+4K162025IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V.20161—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+4K150193Customer Remote Console (CRC)Ge Medical Systems, LLC201512—
+4K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+4K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+4K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+4K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+4K130228SuiteheartNeosoft, LLC20130—
+4K113620Myrian 1.11Intrasense20126—
+4K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+4K120484Visia OncologyMeVis Medical Solutions AG20128—
+4K113541Clearstart SVM SystemIntio, Inc.201171
+4K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+4K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+4K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+4K071241LMS-LiverMedian Technologies20079—
+4K061214Aquariusaps ServerTerarecon,Inc.2006134—
+5K260597Virtue QAProNova Solutions20260—
+5K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+5K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K251363ProKnow DSElekta Solutions AB20250—
+5K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K233660nCommand Lite SystemIonic Health20240—
+5K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+5K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+5K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+5K220813Art-PlanTherapanacea20224—
+5K212915MVision AI SegmentationMVision AI20221—
+5K220779XDMirada Medical, Ltd.20220—
+5K212887RTappSegana, Inc.20210—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K200899Quantib AI NodeQuantib B.V.20200—
+5K200179Collaboration LivePhilips Health Care20204—
+5K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+5K191125ADAS 3DGalgo Medical S.L20205—
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K192424Mobius3DVarian Medical Systems, Inc.20194—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+5K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+5K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+5K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K163253Arterys Cardio DLArterys, Inc.20174—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K162513Arterys Software v2.0Arterys, Inc.20165—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K162112Caas MRVPie Medical Imaging BV20162—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+5K160088Cydar EVCydar, Ltd.20167—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+5K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+5K142647mint LesionMint Medical GmbH201523
+5K132853NovapacsNovarad Corp.201462
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—