510(k) Report

Devices descending from K041521

469 later devices reach Volume Viewer Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+3K133521Aze Phoenix SoftwareAze, Ltd.20140—
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+3K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+3K130228SuiteheartNeosoft, LLC20130—
+3K113620Myrian 1.11Intrasense20126—
+3K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+3K120484Visia OncologyMeVis Medical Solutions AG20128—
+3K113541Clearstart SVM SystemIntio, Inc.201171
+3K111642Onco Trac Model 1, 2, 4Translational Sciences Corporation20113—
+3K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+3K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+3K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+3K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+3K071241LMS-LiverMedian Technologies20079—
+4K260597Virtue QAProNova Solutions20260—
+4K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+4K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.20260—
+4K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+4K251363ProKnow DSElekta Solutions AB20250—
+4K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+4K233660nCommand Lite SystemIonic Health20240—
+4K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+4K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+4K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+4K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+4K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+4K220813Art-PlanTherapanacea20224—
+4K212915MVision AI SegmentationMVision AI20221—
+4K220779XDMirada Medical, Ltd.20220—
+4K212887RTappSegana, Inc.20210—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+4K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+4K202928DV. TargetDeepvoxel, Inc.20210—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K200899Quantib AI NodeQuantib B.V.20200—
+4K200179Collaboration LivePhilips Health Care20204—
+4K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+4K191125ADAS 3DGalgo Medical S.L20205—
+4K192424Mobius3DVarian Medical Systems, Inc.20194—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+4K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+4K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K173542Arterys Oncology DLArterys, Inc.20185—
+4K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K163253Arterys Cardio DLArterys, Inc.20174—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K162513Arterys Software v2.0Arterys, Inc.20165—
+4K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+4K162112Caas MRVPie Medical Imaging BV20162—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+4K160088Cydar EVCydar, Ltd.20167—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+4K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+4K142647mint LesionMint Medical GmbH201523
+4K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+4K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+4K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+4K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+4K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+5K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K243884TavipilotCaranx Medical20250—
+5K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—