510(k) Report

Devices descending from K963345

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170195QuantXQuantitative Insights, Inc.20174—
+7K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+7K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+7K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+7K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+7K141329RadspaTelerad Tech Private Limited20140—
+7K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+7K121213VitreaadvancedVital Images, Inc.201281
+7K121023Spectrum V.0Intrinsic Medical Imaging20120—
+7K120207VISIAMeVis Medical Solutions AG20120—
+7K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+7K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+7K083691BonevueMicromri, Inc.20090—
+7K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+7K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+7K072821Vitrea 4DCTVital Images, Inc.2008171
+8K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+8K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K250039HPACSHealthhub20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+8K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243069Lumys (V1)Intradys20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K243189TumorSight VizSimBioSys, Inc.20241—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K233457RUSHutom, Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+8K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+8K230023ART-PlanTherapanacea Sas20233—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K210670BU-CADTaihao Medical, Inc.20213—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K192437Arterys MICAArterys, Inc.20202—
+8K192277CardIQ FlowGE Medical Systems SCS20200—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+8K190764SurgicalARMedivis, Inc.20196—
+8K190232Synapse PACSFujifilm Corporation2019311
+8K183012vascuCAPElucid Bioimaging, Inc.20182—
+8K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+8K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+8K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+8K173475Merge PACSMerge Healthcare Incorporated201712
+8K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+8K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+8K163668SuitestensaEbit Srl20170—
+8K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+8K153289HealthmyneHealthmyne, Inc.20160—
+8K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+8K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+8K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+8K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+8K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K260086CadAI-B DxBeamWorks, Inc.20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K261210Cleerly PlaqueCleerly, Inc.20260—
+9K260588Cleerly LABSCleerly, Inc.20260—
+9K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K251766TumorSight VizSimBioSys, Inc.20250—
+9K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—