510(k) Report

Devices descending from K963345

472 later devices reach Advantage Windows Tissue Volume Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+6K200323AutoContourRadformation, Inc.20207—
+6K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K193220Aview LCSCoreline Soft Co., Ltd.20201—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K190868Cleerly LabsCleerly, Inc.20197—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+6K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K171754NovaPACSNovarad Corporation201741
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K163574Multi Modality ViewerVital Images, Inc.20171—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K151780CAAS WorkstationPie Medical Imaging BV20169—
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+6K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+6K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+6K142647mint LesionMint Medical GmbH201523
+6K150738VitreaViewVital Images, Inc.20158—
+6K143044CAAS A-ValvePie Medical Imaging BV20150—
+6K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K092954Cadstream Version 5Confirma, Inc.200983
+6K091001Myrian 1.4Intrasense20097—
+6K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+6K081556Cadstream, Version 5.0Confirma, Inc.20099—
+6K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+6K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+6K071241LMS-LiverMedian Technologies20079—
+6K071331Vitrea Version 4.0Vital Images, Inc.2007821
+6K071000MyrianIntrasense20078—
+6K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+7K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+7K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+7K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K231662Aid-UIaid20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K231130TumorSight VizSimBioSys, Inc.20232—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K220813Art-PlanTherapanacea20224—
+7K212915MVision AI SegmentationMVision AI20221—
+7K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+7K210831OnQ NeuroCortechs Labs, Inc.20213—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K201710A View LCSCoreline Soft Co., Ltd.20200—
+7K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+7K182034Arterys MICAArterys, Inc.20183—
+7K182230Multi Modality ViewerVital Images, Inc.20180—
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K163071vascuCAPElucid Bioimaging, Inc.20173—