510(k) Report

Devices descending from K033374

295 later devices reach Lungcare CT Software Package with Extended Functionality through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+6K231662Aid-UIaid20241—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K220813Art-PlanTherapanacea20224—
+6K212915MVision AI SegmentationMVision AI20221—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K210831OnQ NeuroCortechs Labs, Inc.20213—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+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—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K182034Arterys MICAArterys, Inc.20183—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K250039HPACSHealthhub20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K230023ART-PlanTherapanacea Sas20233—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K163668SuitestensaEbit Srl20170—
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K252362GBrain MRIGalileo Cds, Inc.20250—