510(k) Report

Devices descending from K904519

438 later devices reach Agfa Diagnostic Center (Adc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+9K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+9K161201ClearRead CTRiverain Technologies, LLC20165—
+9K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+9K151988Visible Patient SuiteVisible Patient, Sas20154—
+9K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+9K133521Aze Phoenix SoftwareAze, Ltd.20140—
+9K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+9K123920Syngo.ViaSiemens AG Medical Solutions201363—
+9K113620Myrian 1.11Intrasense20126—
+9K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+9K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+9K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+9K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+10K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+10K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+10K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+10K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+10K251747VEA Align; spineEOSEos Imaging20251—
+10K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+10K251096PeekMed webPeek Health, S.A.20253—
+10K242919V5med Lung AIV5med, Inc.20250—
+10K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+10K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+10K231917VEA AlignEos Imaging20245—
+10K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+10K230249IkshanaImmersivetouch20231—
+10K221870CarnaLife HoloMedapp S.A.20230—
+10K222275Saige-DensityDeepHealth, Inc.20221—
+10K221612ClearRead CTRiverain Technologies, Inc.20220—
+10K213215VSI HoloMedicineApoqlar GmbH20222—
+10K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+10K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+10K220813Art-PlanTherapanacea20224—
+10K212915MVision AI SegmentationMVision AI20221—
+10K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+10K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+10K210831OnQ NeuroCortechs Labs, Inc.20213—
+10K212896Visible Patient SuiteVisible Patient, Sas20213—
+10K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+10K211655aPROMISEExini Diagnostics AB20211—
+10K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+10K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+10K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+10K202928DV. TargetDeepvoxel, Inc.20210—
+10K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+10K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+10K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+10K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+10K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+10K193252Contour ProtegeAIMim Software, Inc.20206—
+10K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+10K200935Mazor XMazor Robotics, Ltd.202015—
+10K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+10K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+10K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+10K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+10K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+10K182034Arterys MICAArterys, Inc.20183—
+10K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+10K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+10K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+10K150843syngo®.via (version VB10A)Siemens AG201546—
+10K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+10K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+10K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+11K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+11K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+11K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+11K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+11K251577Laia XRAugmented Reality Software S.L.20260—
+11K252856PeekMed webPeek Health, S.A.20251—
+11K251078AutoDensityEos Imaging20250—
+11K252452PeekMed webPeek Health, S.A.20250—
+11K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+11K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+11K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+11K250416GBrain MRIGalileo Cds, Inc.20251—
+11K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+11K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+11K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+11K241561MammoScreen BDTherapixel20241—
+11K240094LumiNE US; LumiAugmedit B.V.20240—
+11K233457RUSHutom, Inc.20240—
+11K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+11K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+11K230023ART-PlanTherapanacea Sas20233—
+11K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+11K220590aPROMISE XExini Diagnostics AB20220—
+11K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+11K210632Contour ProtegeAIMim Software, Inc.20215—
+11K203005Mazor XMazor Robotics, Ltd.2020141
+11K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+11K192437Arterys MICAArterys, Inc.20202—
+11K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+11K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+11K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+11K190232Synapse PACSFujifilm Corporation2019311
+11K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—