510(k) Report

Devices descending from K010938

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+6K142647mint LesionMint Medical GmbH201523
+6K122136VitreaviewVital Images, Inc.201215—
+6K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+6K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+6K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+6K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+6K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+7K251417ReVISION 2Argus Cognitive, Inc.20260—
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+7K260300WatchMate SoftwareAnumana, Inc.20260—
+7K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+7K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+7K252195ARTICOR plannerArtiness S.R.L20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+7K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+7K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K251747VEA Align; spineEOSEos Imaging20251—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250670EchoConfidence (USA)Mycardium AI Limited20250—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated20250—
+7K242166TribusConnectTribusmed Beheer BV20250—
+7K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+7K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233217Mimics Cardiac PlannerMaterialise NV20240—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+7K232479ART-PlanTherapanacea20232—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+7K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K222406Clarius AIClarius Mobile Health Corp.20233—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K212376Caas QardiaPie Medical Imaging BV20220—
+7K203744Arterys MICAArterys, Inc.20221—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+7K213275EchoGo Core (2.0)Ultromics Limited20211—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+7K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+7K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+7K200603AAA ModelPhilips Ultrasound, Inc.20200—
+7K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+7K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+7K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K171754NovaPACSNovarad Corporation201741
+7K170747syngo Application SoftwareSiemens Medical Solutions USA, Inc.20179—
+7K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+7K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+7K150738VitreaViewVital Images, Inc.20158—
+7K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+7K131158CorviewMarrek, Inc.20130—
+7K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—