510(k) Report

Devices descending from K022013

379 later devices reach Lungcare CT Software Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K230023ART-PlanTherapanacea Sas20233—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+6K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+6K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K192437Arterys MICAArterys, Inc.20202—
+6K192277CardIQ FlowGE Medical Systems SCS20200—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K190232Synapse PACSFujifilm Corporation2019311
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+6K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K171754NovaPACSNovarad Corporation201741
+6K163668SuitestensaEbit Srl20170—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+6K142647mint LesionMint Medical GmbH201523
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+6K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+7K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K231662Aid-UIaid20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K232479ART-PlanTherapanacea20232—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K203744Arterys MICAArterys, Inc.20221—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—