510(k) Report

Devices descending from K033712

442 later devices reach Modification to Sectra IDS5 Radiology Workstation - Version 10.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc.20050—
+1K051743R2 Breast Imaging WorkstationR2 Technology, Inc.20051—
+1K043216Cadstream Version 4.0Confirma, Inc.2005263—
+1K041935DR Systems Pacs, Release 6.1Dr Systems, Inc.200416
+1K040376Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D PackageSectra-Imtec AB2004439—
+2K211039BIT-MotionDde Mri Solutions, Ltd.20210—
+2K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K081168Brit Pacs SystemsBrit Systems, Inc.20090—
+2K081556Cadstream, Version 5.0Confirma, Inc.20099—
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+2K071492FirstviewRiverain Medical Group,Llc20070—
+2K070244AEGISSentinelle Medical, Inc.200789—
+2K061672Synapse Mip/MPR Image Visualization Software ObliquusFujifilm Medical Systems U.S.A, Inc.200612—
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+2K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+2K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+2K050196Sectra IDS5 WorkstationSectra Imtec AB200536—
+2K042868Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc.20057—
+2K042313Integradweb MPR/MipDynamic Imaging, Inc.2004114—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K161959ClearView cCADClearview Diagnostics, Inc.2016131
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+3K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+3K123420Syngo, Breast CareSiemens Medical Solutions USA, Inc.201331
+3K120472QuantraHologic, Inc.20123—
+3K102000ImagysKeosys Sas20103—
+3K100881Synapse Obliquus Mip/MPR/FusionFujifilm Medical System U.S.A., Inc.20101—
+3K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation20092—
+3K082483QuantraHologic, Inc.200825—
+3K081215VoluminaKjaya Medical, LLC20080—
+3K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions2008187
+3K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+3K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+3K070089Syntermed LiveSyntermed, Inc.20070—
+3K070080IntelepacsIntelerad Medical Systems, Inc.200752
+3K061421Erad PacsErad, Inc.200614—
+3K052545Infinitt G3 PacsInfinitt Co., Ltd.200520—
+3K052358Etiam Star Pacs ComponentsEtiam, S.A.200556—
+3K052461Syngo Imaging Version V20ASiemens AG Medical Solutions200523
+3K051315Modification to: Sectra IDS5 WorkstationSectra Imtec AB2005351
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K212621MAMMOVISTA B.smartSiemens Medical Solutions USA, Inc.20212—
+4K190442Koios DS for BreastKoios Medical, Inc.201912—
+4K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+4K172803Infinitt PACS 7.0Infinitt Healthcare Co., Ltd.20173—
+4K163290INFINITT ULiteInfinitt Co., Ltd.20176—
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+4K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+4K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K142037QuantraHologic, Inc.20141—
+4K141329RadspaTelerad Tech Private Limited20140—
+4K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+4K132742M-VU Breast DensityVucomp, Inc.201311—
+4K132799Clariso PacsClariso, Inc.20134—
+4K131392Etiam Pacs ComponentsEtiam S.A.S.U.20130—
+4K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+4K124048ImagequbeIntuitive Imaging Informatics, LLC20130—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+4K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions2012161
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K110332Clearcanvas Ris / PacsClearcanvas, Inc.201141
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K102556Volpara, Version 1.3Matakina Technology Limited201024—
+4K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+4K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC20091—
+4K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+4K090481Demasq Imaging Spftware DeviceDemasq Limited20091—
+4K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+4K082990Infinitt XelisInfinitt Co., Ltd.20086—
+4K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+4K070796Chili PacsChili GmbH20070—
+4K063093Sectra Workstation, Version 11.1Sectra Imtec AB2006341
+4K062488IQ-System Pacs SystemImage Information Systems, Ltd.200655—
+4K060210MediportMaxant Technologies, Inc.20060—
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K251484CT:VQ4Dmedical Limited20250—
+5K241694ZeTTA PACSTae Young Soft Co., Ltd.20250—
+5K241223eRAD PACSErad, Inc.20240—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K240385VINTMediimg Corporation20240—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K223660SaintViewInviz Corporation20230—
+5K223501ViewFinder Software Version 1.1Elaitra, Ltd.20230—
+5K213660RadAllyImaging Wave, LLC20230—
+5K223363MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc.20230—
+5K212616Koios DSKoios Medical, Inc.20214—
+5K203555AmCAD-UTAmcad Biomed Corporation20212—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K211480NubeXTechheim Co., Ltd.20215—