510(k) Report

Devices descending from K033400

637 later devices reach Seno Advantage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161130ResolutionMDCalgary Scientific, Inc.20164—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153014Mobius3DMobius Medical Systems, LP201613—
+4K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+4K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V.20163—
+4K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+4K143514Panther StereoSeedProwess, Inc.20150—
+4K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+4K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+4K151438Dentrix Ascend ImagingRealcloud Imaging, Inc.20150—
+4K142850McKesson Radiology Mammography PlusMckesson Medical Imaging Company20150—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+4K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K142037QuantraHologic, Inc.20141—
+4K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+4K132684Medws Software (Variants Medview, Meddiag, Medmammo)Medecom Sarl20140—
+4K133730CO Pilot/Regius UniteaKonica Minolta, Inc.20142—
+4K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K123575MammoworkstationImage Diagnost International GmbH20132—
+4K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K121663ClarityElekta, Ltd.20121—
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+4K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+4K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K260500ResolutionMDResolutionMD, Inc.20260—
+5K253111Aeka ImagingGood Methods Global, Inc.20260—
+5K251484CT:VQ4Dmedical Limited20250—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+5K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+5K232514MIM – Dose AnalysisMim Software, Inc.20240—
+5K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+5K230023ART-PlanTherapanacea Sas20233—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K212616Koios DSKoios Medical, Inc.20214—
+5K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K203785ClariSIGMAMClaripi, Inc.20210—
+5K203555AmCAD-UTAmcad Biomed Corporation20212—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+5K210066ImagePilotKonica Minolta, Inc.202111
+5K201411Visage Breast DensityVisage Imaging GmbH20210—
+5K201555EchoGo ProUltromics, Ltd.20206—
+5K200323AutoContourRadformation, Inc.20207—
+5K201232Limbus ContourLimbus Ai, Inc.20202—
+5K201798myQA iONIba Dosimetry GmbH202011
+5K192973densitas densityaiDensitas, Inc.20205—
+5K191610RTappSegana, LLC20191—
+5K191761Mobius3DVarian Medical Systems, Inc.20195—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+5K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K182966PLANET Onco DoseDosisoft20191—
+5K182624MIM - MRT DosimetryMim Software, Inc.201853—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K182016Simplicit90YMirada Medical, Ltd.20183—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+5K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K173574DenSeeMammoStatlife20180—
+5K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+5K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd.20182—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K171350Collision CheckRadformation, Inc.20174—
+5K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+5K163623QuantraHologic, Inc.20170—
+5K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+5K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K1619555D ViewerSamsung Medison Co., Ltd.20163—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—