510(k) Report

Devices descending from K033412

136 later devices reach Mediclung, Release 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041807Lung Car 1.1Medicsight2004135—
+2K061214Aquariusaps ServerTerarecon,Inc.2006134—
+3K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+3K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+3K132853NovapacsNovarad Corp.201462
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K121916IntuitionTerarecon,Inc.201351
+3K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200274CariCloudCaristo Diagnostics20200—
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K160371NovaPACSNovarad Corporation20165—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K171754NovaPACSNovarad Corporation201741
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K231662Aid-UIaid20241—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+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—
+7K250039HPACSHealthhub20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+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—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—