510(k) Report

Devices descending from K033400

637 later devices reach Seno Advantage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K143361Mammo WorkstationGE Healthcare20151—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K141855ClarityElekta, Ltd.20140—
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K121213VitreaadvancedVital Images, Inc.201281
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K113620Myrian 1.11Intrasense20126—
+5K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K260597Virtue QAProNova Solutions20260—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+6K250181AV ViewerPhilips Medical Systems Nederland B.V.20251—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+6K243614Sonio SuspectSonio20251—
+6K242130Koios DSKoios Medical, Inc.20241—
+6K242342Fetal EchoScanBrightheart20242—
+6K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+6K241245EchoSolv ASEcho IQ, Ltd.20240—
+6K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+6K234141AISAP Cardio V1.0Aisap20240—
+6K240281Bone Suppression SoftwareKonica Minolta, Inc.20240—
+6K232479ART-PlanTherapanacea20232—
+6K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K230575Limbus ContourLimbus Ai, Inc.20231—
+6K222275Saige-DensityDeepHealth, Inc.20221—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K212915MVision AI SegmentationMVision AI20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K220767TeleScanBb Imaging20221—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K210831OnQ NeuroCortechs Labs, Inc.20213—
+6K212887RTappSegana, Inc.20210—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K203235VBrainVysioneer, Inc.20214—
+6K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+6K192424Mobius3DVarian Medical Systems, Inc.20194—
+6K190232Synapse PACSFujifilm Corporation2019311
+6K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+6K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+6K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K182034Arterys MICAArterys, Inc.20183—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K1808835D ViewerSamsung Medison Co., Ltd.20180—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+6K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K1725133D EchoJointvue, LLC20171—
+6K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+6K163668SuitestensaEbit Srl20170—
+6K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+6K160937SenolrisGE Healthcare20160—