510(k) Report

Devices descending from K982004

274 later devices reach CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K210831OnQ NeuroCortechs Labs, Inc.20213—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+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
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K121213VitreaadvancedVital Images, Inc.201281
+8K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K243859PRAEVAorta®2Nurea20250—
+8K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+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—
+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—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+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—
+8K153289HealthmyneHealthmyne, Inc.20160—
+8K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+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—
+9K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+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—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K203744Arterys MICAArterys, Inc.20221—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+9K192455Merge PACSMerge Healthcare Incorporated201904
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K190178Monaco RTP SystemElekta, Inc.201945
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K151988Visible Patient SuiteVisible Patient, Sas20154—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K252539Tempus PixelArterys, Inc.20250—
+10K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—