510(k) Report

Devices descending from K043216

263 later devices reach Cadstream Version 4.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211039BIT-MotionDde Mri Solutions, Ltd.20210—
+1K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+1K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+1K081556Cadstream, Version 5.0Confirma, Inc.20099—
+1K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+1K070244AEGISSentinelle Medical, Inc.200789—
+1K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+1K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+1K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+2K170195QuantXQuantitative Insights, Inc.20174—
+2K161959ClearView cCADClearview Diagnostics, Inc.2016131
+2K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+2K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+2K092954Cadstream Version 5Confirma, Inc.200983
+2K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+2K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+3K231130TumorSight VizSimBioSys, Inc.20232—
+3K210670BU-CADTaihao Medical, Inc.20213—
+3K190442Koios DS for BreastKoios Medical, Inc.201912—
+3K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+3K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+3K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+3K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+3K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+3K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+3K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+3K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+3K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+3K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+3K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+3K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+4K260086CadAI-B DxBeamWorks, Inc.20260—
+4K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+4K251484CT:VQ4Dmedical Limited20250—
+4K243189TumorSight VizSimBioSys, Inc.20241—
+4K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+4K212616Koios DSKoios Medical, Inc.20214—
+4K203555AmCAD-UTAmcad Biomed Corporation20212—
+4K201555EchoGo ProUltromics, Ltd.20206—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+4K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+4K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+4K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+4K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+4K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K1619555D ViewerSamsung Medison Co., Ltd.20163—
+4K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+4K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+4K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+4K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+4K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+4K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+4K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+4K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+4K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+4K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+5K251766TumorSight VizSimBioSys, Inc.20250—
+5K243614Sonio SuspectSonio20251—
+5K242130Koios DSKoios Medical, Inc.20241—
+5K242342Fetal EchoScanBrightheart20242—
+5K241245EchoSolv ASEcho IQ, Ltd.20240—
+5K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+5K234141AISAP Cardio V1.0Aisap20240—
+5K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+5K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+5K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K1808835D ViewerSamsung Medison Co., Ltd.20180—
+5K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K1725133D EchoJointvue, LLC20171—
+5K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—