510(k) Report

Devices descending from K022013

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K191530StoneCheckerImaging Biometrics, LLC20191—
+4K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+4K180867AmCAD-UOAmcad Biomed Corporation20180—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K181572Workflow BoxMirada Medical, Ltd.201825—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K173542Arterys Oncology DLArterys, Inc.20185—
+4K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+4K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+4K132853NovapacsNovarad Corp.201462
+4K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K121916IntuitionTerarecon,Inc.201351
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+4K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+4K071241LMS-LiverMedian Technologies20079—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K251883MIM – LesionID ProMim Software, Inc.20250—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+5K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220813Art-PlanTherapanacea20224—
+5K212915MVision AI SegmentationMVision AI20221—
+5K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K200274CariCloudCaristo Diagnostics20200—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K182034Arterys MICAArterys, Inc.20183—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K160371NovaPACSNovarad Corporation20165—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+5K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+5K121213VitreaadvancedVital Images, Inc.201281
+5K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—