510(k) Report

Devices descending from K010938

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K120282CardnavPaieon, Inc.20120—
+7K120514CardiopacsLumedx20120—
+8K260192DIANAROPCA ApS20260—
+8K260528OncoStudioOncosoft. Inc.,20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+8K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+8K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+8K251078AutoDensityEos Imaging20250—
+8K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K252539Tempus PixelArterys, Inc.20250—
+8K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—
+8K250484PIUR tUS insidePiur Imaging GmbH20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+8K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+8K242359Strain AI (SAI001)Exo, Inc.20240—
+8K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+8K234141AISAP Cardio V1.0Aisap20240—
+8K233457RUSHutom, Inc.20240—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K231662Aid-UIaid20241—
+8K232501AI Platform (AIP001)Exo, Inc.20231—
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+8K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+8K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+8K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+8K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+8K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+8K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+8K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+8K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+8K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+8K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+8K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+8K173611syngo Application SoftwareSiemens Medical Solutions USA, Inc.20188—
+8K163232Vitrea ViewVital Images, Inc.20177—
+8K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+8K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252007BlineSlideDeep Breathe, Inc.20250—
+9K250039HPACSHealthhub20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+9K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+9K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+9K243684BrightHeart View ClassifierBrightheart20251—
+9K243069Lumys (V1)Intradys20250—
+9K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+9K240645Sonix HealthOntact Health Co., Ltd.20240—
+9K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+9K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+9K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—