510(k) Report

Devices descending from K010938

721 later devices reach Syngo Multimodality Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K131996S-SCANEsaote, S.p.A.20139—
+4K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K120288Orthocad Software OptionEsaote, S.p.A.20120—
+4K122006G-Scan BrioEsaote, S.p.A.201211—
+4K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+4K103815Q-StationPhilips Ultrasound, Inc.20111—
+4K092915Cedara Webaccess, Model: 2.4Cedara Software Corp.2010214
+4K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc.20100—
+4K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+4K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+4K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+4K070322Syngo Dynamics, Version 6.0Siemens Medical Solutions USA, Inc.200792
+4K061214Aquariusaps ServerTerarecon,Inc.2006134—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K260746S-scan Open (100001800)Esaote, S.p.A.20261—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K251215Philips IntelliSpace CardiovascularPhilips Medical Systems Nederland B.V.20250—
+5K251484CT:VQ4Dmedical Limited20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K223501ViewFinder Software Version 1.1Elaitra, Ltd.20230—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+5K223363MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc.20230—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+5K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+5K220813Art-PlanTherapanacea20224—
+5K212915MVision AI SegmentationMVision AI20221—
+5K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+5K212419Magnifico Open, Magnifico MSKEsaote, S.p.A.20222—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+5K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+5K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K190993Kinepict Medical Imaging Tool version v2.2Kinepict Health, Ltd.20201—
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K182034Arterys MICAArterys, Inc.20183—
+5K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+5K182290IBM iConnect AccessMerge Healthcare Incorporated20183—
+5K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+5K172346sterEOS WorkstationEos Imaging201871
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K162376CAAS MR 4D FlowPie Medical Imaging BV20163—
+5K162541syngo Application SoftwareSiemens Medical Solutions USA, Inc.201635—
+5K162513Arterys Software v2.0Arterys, Inc.20165—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K1537363mensio WorkstationPie Medical Imaging BV2016191
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+5K151668S-scanEsaote, S.p.A.20158—
+5K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K132853NovapacsNovarad Corp.201462