510(k) Report

Devices descending from K974715

298 later devices reach Advantage 3D XR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K173821LungQ SoftwareThirona Corporation20183—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+6K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+6K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+6K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+6K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+6K121449DirectpathCybernet Systems Co., Ltd.20120—
+6K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+6K093810BF-NaviKgt, Inc.20101—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K251199Allia MoveoGE Medical Systems SCS202501
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K233875Brainomix 360 e-LungBrainomix Limited20241—
+7K232412LungQ v3.0.0Thirona BV20241—
+7K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+7K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+7K223424Spine Auto ViewsGE Medical Systems SCS20230—
+7K223556DeepCatchMedical IP Co., Ltd.20231—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K212494Lung Image AnalysisPulmonx Corporation20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K171199AVIEWCoreline Soft Co., Ltd.20186—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+7K161201ClearRead CTRiverain Technologies, LLC20165—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+7K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+7K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+7K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+7K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+7K133521Aze Phoenix SoftwareAze, Ltd.20140—
+7K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+7K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+7K113620Myrian 1.11Intrasense20126—
+7K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+7K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+7K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+8K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+8K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K250766LungQ 4Thirona BV20250—
+8K251484CT:VQ4Dmedical Limited20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K242411Brainomix 360 e-LungBrainomix Limited20250—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K221612ClearRead CTRiverain Technologies, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K200714AVIEWCoreline Soft Co., Ltd.20205—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+8K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—