510(k) Report

Devices descending from K012313

580 later devices reach CT Colonography/NAVIGATOR2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+7K252500CARA SystemCara Medical, Ltd.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K243301MapRTVision Rt, Ltd.20250—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K250099Mobius3D (4.1)Varian Medical Systems20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+7K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K232479ART-PlanTherapanacea20232—
+7K223834AccuCheckManteia Technologies Co., Ltd.20231—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+7K212421ADAS 3DAdas3D Medical S.L.20213—
+7K212383EndoNautTherenva Sas20212—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K192437Arterys MICAArterys, Inc.20202—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K171754NovaPACSNovarad Corporation201741
+7K163668SuitestensaEbit Srl20170—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K260528OncoStudioOncosoft. Inc.,20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+8K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+8K250696AccuCheckManteia Technologies Co., Ltd.20250—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K250484PIUR tUS insidePiur Imaging GmbH20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K241302SonoSyncSamsung Medison Co., Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K231662Aid-UIaid20241—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K230803ADAS 3DAdas3D Medical S.L.20232—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K222070EndoNautTherenva Sas20221—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K203744Arterys MICAArterys, Inc.20221—