510(k) Report

Devices descending from K913770

1,148 later devices reach Advantage V.S. CT/MR Rad Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251883MIM – LesionID ProMim Software, Inc.20250—
+6K250039HPACSHealthhub20250—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K241223eRAD PACSErad, Inc.20240—
+6K240786AutoChamberHeartLung Corporation20241—
+6K233457RUSHutom, Inc.20240—
+6K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+6K232976VUZE SystemVuze Medical, Ltd.20240—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K233660nCommand Lite SystemIonic Health20240—
+6K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+6K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH20234—
+6K231061NeuroBlate SystemMonteris Medical,20236—
+6K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+6K223261Open RibCanon Medical Informatics, Inc.20230—
+6K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+6K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB20227—
+6K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+6K202084DeepLook PRECISEDeeplook, Inc.20210—
+6K210850ADAS 3DAdas3D Medical S.L.20214—
+6K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+6K201583SmartCT R1.0Philips Medical Systems Nederland B.V.20211—
+6K202700ART-PlanTherapanacea20215—
+6K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+6K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+6K200822BraidBraid.Health20201—
+6K200899Quantib AI NodeQuantib B.V.20200—
+6K200274CariCloudCaristo Diagnostics20200—
+6K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+6K200179Collaboration LivePhilips Health Care20204—
+6K193375NeuroBlate SystemMonteris Medical,202010—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+6K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+6K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+6K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+6K190379MIM on LinuxMim Software, Inc.201914—
+6K182855ProKnow DSProknow, LLC20192—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K182034Arterys MICAArterys, Inc.20183—
+6K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+6K173305NeuroBlate SystemMonteris Medical,201712—
+6K170130Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V.20171—
+6K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+6K170724NeuroBlate SystemMonteris Medical,201715—
+6K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+6K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+6K161959ClearView cCADClearview Diagnostics, Inc.2016131
+6K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+6K161973G-scan Brio, S-scanEsaote, S.p.A.20165—
+6K160371NovaPACSNovarad Corporation20165—
+6K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+6K161419Multi Modality ViewerVital Images, Inc.20162—
+6K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+6K152977DG PacsDicom Grid, Inc.201641
+6K151957BOX DICOM ViewerBox, Inc.20153—
+6K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V.20158—
+6K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K150746JUSHA-M52C Medical DisplayNanjing Jusha Display Technology Co., Ltd.20150—
+6K142647mint LesionMint Medical GmbH201523
+6K142421G-scan BrioEsaote, S.p.A.201591
+6K142273EmboGuidePhilips Medical Systems Nederland B.V.20151—
+6K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+6K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+6K141983Neuroblate SystemMonteris Medical Corp.2014182
+6K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+6K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+6K133993Caas WorkstationPie Medical Imaging201410—
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+6K132342XVWEBApteryx, Inc.20133—
+6K131996S-SCANEsaote, S.p.A.20139—
+6K132523MyoperfusionToshibamedical Systems Corporation201311
+6K132742M-VU Breast DensityVucomp, Inc.201311—
+6K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+6K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd.20130—
+6K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+6K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+6K120851Communify Pacs ViewerCommunify Health, LLC20130—
+6K123530Mammography Prior Enhancement (Mpe)Hologic, Inc.20120—
+6K120282CardnavPaieon, Inc.20120—
+6K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+6K120288Orthocad Software OptionEsaote, S.p.A.20120—
+6K122006G-Scan BrioEsaote, S.p.A.201211—