510(k) Report

Devices descending from K040376

439 later devices reach Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061672Synapse Mip/MPR Image Visualization Software ObliquusFujifilm Medical Systems U.S.A, Inc.200612—
+1K052537Catella Diagnostic Workstation, Version 4.0American Medical Sales, Inc.20050—
+1K050196Sectra IDS5 WorkstationSectra Imtec AB200536—
+1K043216Cadstream Version 4.0Confirma, Inc.2005263—
+1K042868Mammoreport Softcopy WorkstationSiemens Medical Solutions USA, Inc.20057—
+1K042313Integradweb MPR/MipDynamic Imaging, Inc.2004114—
+1K041935DR Systems Pacs, Release 6.1Dr Systems, Inc.200416
+2K211039BIT-MotionDde Mri Solutions, Ltd.20210—
+2K123420Syngo, Breast CareSiemens Medical Solutions USA, Inc.201331
+2K120472QuantraHologic, Inc.20123—
+2K102000ImagysKeosys Sas20103—
+2K100881Synapse Obliquus Mip/MPR/FusionFujifilm Medical System U.S.A., Inc.20101—
+2K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation20092—
+2K081168Brit Pacs SystemsBrit Systems, Inc.20090—
+2K081556Cadstream, Version 5.0Confirma, Inc.20099—
+2K082483QuantraHologic, Inc.200825—
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+2K081215VoluminaKjaya Medical, LLC20080—
+2K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions2008187
+2K070089Syntermed LiveSyntermed, Inc.20070—
+2K070244AEGISSentinelle Medical, Inc.200789—
+2K070080IntelepacsIntelerad Medical Systems, Inc.200752
+2K061421Erad PacsErad, Inc.200614—
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+2K052545Infinitt G3 PacsInfinitt Co., Ltd.200520—
+2K052358Etiam Star Pacs ComponentsEtiam, S.A.200556—
+2K052461Syngo Imaging Version V20ASiemens AG Medical Solutions200523
+2K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+2K051315Modification to: Sectra IDS5 WorkstationSectra Imtec AB2005351
+2K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+3K212621MAMMOVISTA B.smartSiemens Medical Solutions USA, Inc.20212—
+3K172803Infinitt PACS 7.0Infinitt Healthcare Co., Ltd.20173—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K163290INFINITT ULiteInfinitt Co., Ltd.20176—
+3K161959ClearView cCADClearview Diagnostics, Inc.2016131
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K142037QuantraHologic, Inc.20141—
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+3K141329RadspaTelerad Tech Private Limited20140—
+3K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+3K132742M-VU Breast DensityVucomp, Inc.201311—
+3K132799Clariso PacsClariso, Inc.20134—
+3K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+3K131392Etiam Pacs ComponentsEtiam S.A.S.U.20130—
+3K124048ImagequbeIntuitive Imaging Informatics, LLC20130—
+3K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc.20127—
+3K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions2012161
+3K110332Clearcanvas Ris / PacsClearcanvas, Inc.201141
+3K102556Volpara, Version 1.3Matakina Technology Limited201024—
+3K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100—
+3K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC20091—
+3K090481Demasq Imaging Spftware DeviceDemasq Limited20091—
+3K082990Infinitt XelisInfinitt Co., Ltd.20086—
+3K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+3K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+3K070796Chili PacsChili GmbH20070—
+3K063093Sectra Workstation, Version 11.1Sectra Imtec AB2006341
+3K062488IQ-System Pacs SystemImage Information Systems, Ltd.200655—
+3K060210MediportMaxant Technologies, Inc.20060—
+4K241694ZeTTA PACSTae Young Soft Co., Ltd.20250—
+4K241223eRAD PACSErad, Inc.20240—
+4K240385VINTMediimg Corporation20240—
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K223660SaintViewInviz Corporation20230—
+4K223501ViewFinder Software Version 1.1Elaitra, Ltd.20230—
+4K213660RadAllyImaging Wave, LLC20230—
+4K223363MAMMOVISTA B.smart (VB70)Siemens Medical Solutions USA, Inc.20230—
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K211480NubeXTechheim Co., Ltd.20215—
+4K191530StoneCheckerImaging Biometrics, LLC20191—
+4K190442Koios DS for BreastKoios Medical, Inc.201912—
+4K181460OnePacs SystemOnepacs, LLC20180—
+4K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+4K181318Onis-PacsDigitalcore Co., Ltd.20181—
+4K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+4K173241Med-TabPlum Medical Solutions GmbH20180—
+4K170540DM-DensityDensitas, Inc.20187—
+4K163623QuantraHologic, Inc.20170—
+4K171130Nucleus Image Management SystemNucleushealth, LLC20170—
+4K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K152009DENSEEMAMMO v1.0Statlife20161—
+4K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+4K152977DG PacsDicom Grid, Inc.201641
+4K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+4K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+4K151957BOX DICOM ViewerBox, Inc.20153—
+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—
+4K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K123174Centricity Pacs-IW with Universal ViewerGE Healthcare20121510
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—