510(k) Report

Devices descending from K022919

217 later devices reach Smart Breath Respiratory Compensation Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032915Advantage 4D OptionGe Medical Systems, LLC2003216—
+2K132410Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 WGe Medical Systems, LLC201402
+2K113086ACQATexas Medical Imaging Consultants20120—
+2K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+2K052345Advantage Sim MDGE Healthcare2005213
+3K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+3K130393Mirada RTXMirada Medical, Ltd.201336—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+3K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+4K220779XDMirada Medical, Ltd.20220—
+4K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+4K202700ART-PlanTherapanacea20215—
+4K200323AutoContourRadformation, Inc.20207—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K181572Workflow BoxMirada Medical, Ltd.201825—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K173542Arterys Oncology DLArterys, Inc.20185—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K113620Myrian 1.11Intrasense20126—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+4K071241LMS-LiverMedian Technologies20079—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K220813Art-PlanTherapanacea20224—
+5K212915MVision AI SegmentationMVision AI20221—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+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—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K121213VitreaadvancedVital Images, Inc.201281
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K230023ART-PlanTherapanacea Sas20233—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K192437Arterys MICAArterys, Inc.20202—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K190232Synapse PACSFujifilm Corporation2019311
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+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—