510(k) Report

Devices descending from K063762

263 later devices reach Syngo Circulation Software Package with Extended Functionality through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+4K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K250416GBrain MRIGalileo Cds, Inc.20251—
+5K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+5K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+5K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+5K241440HealthCCSngNano-X AI, Ltd.20240—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+5K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+5K230112CAC SoftwareImbio, Inc.20230—
+5K230223iCAC DeviceBunkerhill, Inc.20236—
+5K230023ART-PlanTherapanacea Sas20233—
+5K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K192437Arterys MICAArterys, Inc.20202—
+5K192277CardIQ FlowGE Medical Systems SCS20200—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+5K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+5K190232Synapse PACSFujifilm Corporation2019311
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K173475Merge PACSMerge Healthcare Incorporated201712
+5K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+5K163668SuitestensaEbit Srl20170—
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+6K261210Cleerly PlaqueCleerly, Inc.20260—
+6K260588Cleerly LABSCleerly, Inc.20260—
+6K260166Bunkerhill Contrast CACBunkerHill Health20260—
+6K250662Bunkerhill MACBunkerHill Health20250—
+6K252362GBrain MRIGalileo Cds, Inc.20250—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+6K243229Bunkerhill AVCBunkerHill Health20253—
+6K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+6K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K232479ART-PlanTherapanacea20232—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K203744Arterys MICAArterys, Inc.20221—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+6K192455Merge PACSMerge Healthcare Incorporated201904
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+6K142647mint LesionMint Medical GmbH201523
+7K260528OncoStudioOncosoft. Inc.,20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K253078ART.1-USSeetreat Pty, Ltd.20260—
+7K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K252539Tempus PixelArterys, Inc.20250—
+7K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—