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
+7K192437Arterys MICAArterys, Inc.20202—
+7K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+7K190868Cleerly LabsCleerly, Inc.20197—
+7K190442Koios DS for BreastKoios Medical, Inc.201912—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc.20180—
+7K182815XVWeb 3DApteryx, Inc.20180—
+7K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+7K180522IGTFusionIgi Technologies20180—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K180549ZED LinkZed Technologies20180—
+7K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+7K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+7K170540DM-DensityDensitas, Inc.20187—
+7K173636VelocityVarian Medical Systems, Inc.20188—
+7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+7K173542Arterys Oncology DLArterys, Inc.20185—
+7K173420Radiomics App v1.0Microsoft Corp.20174—
+7K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+7K172307Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V.20170—
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K171754NovaPACSNovarad Corporation201741
+7K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K163574Multi Modality ViewerVital Images, Inc.20171—
+7K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+7K152009DENSEEMAMMO v1.0Statlife20161—
+7K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+7K161130ResolutionMDCalgary Scientific, Inc.20164—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K160088Cydar EVCydar, Ltd.20167—
+7K153014Mobius3DMobius Medical Systems, LP201613—
+7K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+7K151780CAAS WorkstationPie Medical Imaging BV20169—
+7K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V.20163—
+7K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+7K143514Panther StereoSeedProwess, Inc.20150—
+7K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+7K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+7K151668S-scanEsaote, S.p.A.20158—
+7K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+7K151438Dentrix Ascend ImagingRealcloud Imaging, Inc.20150—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+7K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+7K150738VitreaViewVital Images, Inc.20158—
+7K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+7K143044CAAS A-ValvePie Medical Imaging BV20150—
+7K142850McKesson Radiology Mammography PlusMckesson Medical Imaging Company20150—
+7K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+7K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+7K142037QuantraHologic, Inc.20141—
+7K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+7K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+7K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+7K132684Medws Software (Variants Medview, Meddiag, Medmammo)Medecom Sarl20140—
+7K133730CO Pilot/Regius UniteaKonica Minolta, Inc.20142—
+7K133490G-Scan BrioEsaote, S.p.A.201310—
+7K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+7K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K13113721.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5)Jvckenwood Corporation20131—
+7K123575MammoworkstationImage Diagnost International GmbH20132—
+7K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+7K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+7K121663ClarityElekta, Ltd.20121—
+7K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+7K122205EXINIExini Diagnostics AB20125—
+7K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation20122—
+7K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+7K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+7K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd.20112—
+7K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+7K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+7K101796Pacsmate MMD-5201M MonitorIei Technology Corp.20100—
+7K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+7K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+7K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+7K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd.20083—
+7K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+7K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+7K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+7K071241LMS-LiverMedian Technologies20079—
+7K071331Vitrea Version 4.0Vital Images, Inc.2007821
+7K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+8K262315NeuroBlate SystemMonteris Medical20260—
+8K261331I-Genius (100019400)Esaote, S.p.A.20260—
+8K260500ResolutionMDResolutionMD, Inc.20260—
+8K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+8K260976NeuroBlate SystemMonteris Medical20261—
+8K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K253111Aeka ImagingGood Methods Global, Inc.20260—