510(k) Report

Devices descending from K073003

168 later devices reach Syngo Dual Energy with Extended Functionally through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+1K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+2K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+2K161201ClearRead CTRiverain Technologies, LLC20165—
+2K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+2K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+2K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+2K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+2K133521Aze Phoenix SoftwareAze, Ltd.20140—
+2K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+2K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+2K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+2K113620Myrian 1.11Intrasense20126—
+2K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+2K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+2K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+2K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+3K242919V5med Lung AIV5med, Inc.20250—
+3K221612ClearRead CTRiverain Technologies, Inc.20220—
+3K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+3K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+3K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+3K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+3K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+3K200315Ziostation2Ziosoft, Inc.20200—
+3K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+3K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+3K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+3K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+3K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+3K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+3K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+3K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+3K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+3K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+3K123920Syngo.ViaSiemens AG Medical Solutions201363—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+4K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+4K223261Open RibCanon Medical Informatics, Inc.20230—
+4K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+4K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+4K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+4K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+4K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+4K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+4K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+4K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+5K223424Spine Auto ViewsGE Medical Systems SCS20230—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+5K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+5K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K213944HealthOSTNanoxai, Ltd.20221—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+5K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+5K142647mint LesionMint Medical GmbH201523
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K233080HealthFLDNano-X AI, Ltd.20240—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K220929ExcelsiorMerit Cro, Inc.20220—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K202229AI MetricsAi Metrics, LLC20200—