510(k) Report

Devices descending from K020929

272 later devices reach Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K182034Arterys MICAArterys, Inc.20183—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K121213VitreaadvancedVital Images, Inc.201281
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K243859PRAEVAorta®2Nurea20250—
+7K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230023ART-PlanTherapanacea Sas20233—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K163668SuitestensaEbit Srl20170—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+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—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232479ART-PlanTherapanacea20232—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K203744Arterys MICAArterys, Inc.20221—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K151988Visible Patient SuiteVisible Patient, Sas20154—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K252539Tempus PixelArterys, Inc.20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—