510(k) Report

Devices descending from K022881

413 later devices reach Cedara I-Softview through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231917VEA AlignEos Imaging20245—
+7K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+7K230249IkshanaImmersivetouch20231—
+7K221870CarnaLife HoloMedapp S.A.20230—
+7K222275Saige-DensityDeepHealth, Inc.20221—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K213215VSI HoloMedicineApoqlar GmbH20222—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K220813Art-PlanTherapanacea20224—
+7K212915MVision AI SegmentationMVision AI20221—
+7K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K210831OnQ NeuroCortechs Labs, Inc.20213—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K200935Mazor XMazor Robotics, Ltd.202015—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+7K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K182034Arterys MICAArterys, Inc.20183—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+8K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+8K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+8K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+8K251577Laia XRAugmented Reality Software S.L.20260—
+8K252856PeekMed webPeek Health, S.A.20251—
+8K251078AutoDensityEos Imaging20250—
+8K252452PeekMed webPeek Health, S.A.20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K241561MammoScreen BDTherapixel20241—
+8K240094LumiNE US; LumiAugmedit B.V.20240—
+8K233457RUSHutom, Inc.20240—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+8K230023ART-PlanTherapanacea Sas20233—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K203005Mazor XMazor Robotics, Ltd.2020141
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K192437Arterys MICAArterys, Inc.20202—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K190232Synapse PACSFujifilm Corporation2019311
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K181892Ziostation2Ziosoft, Inc.20181—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K173475Merge PACSMerge Healthcare Incorporated201712
+8K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+8K163668SuitestensaEbit Srl20170—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K151233MonacoImpac Medical Systems, Inc.201569
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K243685MammoScreen BDTherapixel20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K232479ART-PlanTherapanacea20232—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—