510(k) Report

Devices descending from K983877

328 later devices reach Philips Integris 3D RA Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+5K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+5K121449DirectpathCybernet Systems Co., Ltd.20120—
+5K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+5K093810BF-NaviKgt, Inc.20101—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+6K260166Bunkerhill Contrast CACBunkerHill Health20260—
+6K252500CARA SystemCara Medical, Ltd.20260—
+6K251355X1-FFRSpectrawave, Inc.20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K250662Bunkerhill MACBunkerHill Health20250—
+6K243069Lumys (V1)Intradys20250—
+6K243229Bunkerhill AVCBunkerHill Health20253—
+6K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+6K233875Brainomix 360 e-LungBrainomix Limited20241—
+6K232147CAAS WorkstationPie Medical Imaging BV20241—
+6K232412LungQ v3.0.0Thirona BV20241—
+6K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+6K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K223556DeepCatchMedical IP Co., Ltd.20231—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K212494Lung Image AnalysisPulmonx Corporation20210—
+6K212383EndoNautTherenva Sas20212—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K171199AVIEWCoreline Soft Co., Ltd.20186—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+6K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+6K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+6K113620Myrian 1.11Intrasense20126—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+7K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+7K250766LungQ 4Thirona BV20250—
+7K251484CT:VQ4Dmedical Limited20250—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243769QFR (3.0)Qfr Solutions BV20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K242411Brainomix 360 e-LungBrainomix Limited20250—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K222070EndoNautTherenva Sas20221—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K200714AVIEWCoreline Soft Co., Ltd.20205—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—