510(k) Report

Devices descending from K013381

470 later devices reach Advanced Lung Analysis-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K092954Cadstream Version 5Confirma, Inc.200983
+5K091001Myrian 1.4Intrasense20097—
+5K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+5K081556Cadstream, Version 5.0Confirma, Inc.20099—
+5K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+5K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+5K071241LMS-LiverMedian Technologies20079—
+5K071331Vitrea Version 4.0Vital Images, Inc.2007821
+5K071000MyrianIntrasense20078—
+5K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+6K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+6K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K231662Aid-UIaid20241—
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220813Art-PlanTherapanacea20224—
+6K212915MVision AI SegmentationMVision AI20221—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+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—
+6K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+6K202084DeepLook PRECISEDeeplook, Inc.20210—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K201710A View LCSCoreline Soft Co., Ltd.20200—
+6K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+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—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K182034Arterys MICAArterys, Inc.20183—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K182230Multi Modality ViewerVital Images, Inc.20180—
+6K180019CAAS WorkstationPie Medical Imaging BV20188—
+6K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K163071vascuCAPElucid Bioimaging, Inc.20173—
+6K170195QuantXQuantitative Insights, Inc.20174—
+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—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+6K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+6K141329RadspaTelerad Tech Private Limited20140—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+6K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K121023Spectrum V.0Intrinsic Medical Imaging20120—
+6K120207VISIAMeVis Medical Solutions AG20120—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+6K083691BonevueMicromri, Inc.20090—
+6K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+6K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+6K072821Vitrea 4DCTVital Images, Inc.2008171
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+7K251355X1-FFRSpectrawave, Inc.20250—
+7K250039HPACSHealthhub20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+7K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+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—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—