510(k) Report

Devices descending from K970980

276 later devices reach Cardiac Scoring for CT Scanners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212915MVision AI SegmentationMVision AI20221—
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K193252Contour ProtegeAIMim Software, Inc.20206—
+8K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+8K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+8K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+8K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+8K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+8K182034Arterys MICAArterys, Inc.20183—
+8K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+8K151233MonacoImpac Medical Systems, Inc.201569
+8K150843syngo®.via (version VB10A)Siemens AG201546—
+8K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+8K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+8K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K121213VitreaadvancedVital Images, Inc.201281
+9K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K243859PRAEVAorta®2Nurea20250—
+9K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+9K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+9K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K230023ART-PlanTherapanacea Sas20233—
+9K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+9K210632Contour ProtegeAIMim Software, Inc.20215—
+9K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+9K192437Arterys MICAArterys, Inc.20202—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+9K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+9K183037Monaco RTP SystemElekta, Inc.201856
+9K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+9K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K163668SuitestensaEbit Srl20170—
+9K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+9K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+9K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+9K153289HealthmyneHealthmyne, Inc.20160—
+9K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+9K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+10K252362GBrain MRIGalileo Cds, Inc.20250—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+10K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+10K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+10K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+10K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+10K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+10K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+10K232479ART-PlanTherapanacea20232—
+10K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+10K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+10K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+10K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+10K203744Arterys MICAArterys, Inc.20221—
+10K213976Contour ProtégéAIMim Software, Inc.20224—
+10K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+10K201948AcroDTI VisualizerAcroviz, Inc.20200—
+10K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+10K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+10K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+10K192455Merge PACSMerge Healthcare Incorporated201904
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K190178Monaco RTP SystemElekta, Inc.201945
+10K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+10K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+10K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+10K151988Visible Patient SuiteVisible Patient, Sas20154—
+10K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+10K142647mint LesionMint Medical GmbH201523
+11K260528OncoStudioOncosoft. Inc.,20260—
+11K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+11K253078ART.1-USSeetreat Pty, Ltd.20260—
+11K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+11K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+11K252539Tempus PixelArterys, Inc.20250—
+11K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—