510(k) Report

Devices descending from K071114

181 later devices reach Syngo Imaging (Version V30) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+6K142647mint LesionMint Medical GmbH201523
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K241211CoLumboSmart Soft Healthcare20242—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K220497CoLumboSmart Soft Healthcare AD20226—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+7K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH20211—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+7K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+8K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K250367CoLumboXSmart Soft Healthcare AD20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K240793MSKaiMskai20240—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+8K231041JiveX (Model Number / Release: 5.4)Visus Health IT GmbH20230—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+11K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+12K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+12K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+12K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+12K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+12K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+13K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+13K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+14K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+15K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—