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
+5K201555EchoGo ProUltromics, Ltd.20206—
+5K191530StoneCheckerImaging Biometrics, LLC20191—
+5K181460OnePacs SystemOnepacs, LLC20180—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181318Onis-PacsDigitalcore Co., Ltd.20181—
+5K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+5K173241Med-TabPlum Medical Solutions GmbH20180—
+5K170540DM-DensityDensitas, Inc.20187—
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+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—
+5K171130Nucleus Image Management SystemNucleushealth, LLC20170—
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+5K152009DENSEEMAMMO v1.0Statlife20161—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K1619555D ViewerSamsung Medison Co., Ltd.20163—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K152977DG PacsDicom Grid, Inc.201641
+5K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+5K151957BOX DICOM ViewerBox, Inc.20153—
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K123174Centricity Pacs-IW with Universal ViewerGE Healthcare20121510
+5K121213VitreaadvancedVital Images, Inc.201281
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K111660Xelis CardiacInfinitt Co., Ltd.20110—
+5K111613Xelis FusionInfinitt Co., Ltd.20110—
+5K103130Xelis 3DInfinitt Co., Ltd.20110—
+5K100837Pacentric Connect, Traveler and WebFimreite Software AS20100—
+5K102684Xelis DentalInfinitt Co., Ltd.20102—
+5K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+5K081630Mammo WorkstationImage Diagnost International GmbH20084—
+5K081469Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2Sectra Imtec AB20080—
+5K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+5K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH200749—
+6K261874Syneris PACS v.1.0.1.0Syneris20260—
+6K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K243614Sonio SuspectSonio20251—
+6K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+6K242130Koios DSKoios Medical, Inc.20241—
+6K242342Fetal EchoScanBrightheart20242—
+6K241245EchoSolv ASEcho IQ, Ltd.20240—
+6K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+6K234141AISAP Cardio V1.0Aisap20240—
+6K222781AugmentoDeeptek Medical Imaging Private Limited20234—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+6K203785ClariSIGMAMClaripi, Inc.20210—
+6K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K202084DeepLook PRECISEDeeplook, Inc.20210—
+6K201411Visage Breast DensityVisage Imaging GmbH20210—
+6K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+6K200822BraidBraid.Health20201—
+6K201296i-Rapha SolutionIrm, Inc.20200—
+6K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+6K192973densitas densityaiDensitas, Inc.20205—
+6K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+6K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+6K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+6K173574DenSeeMammoStatlife20180—
+6K1808835D ViewerSamsung Medison Co., Ltd.20180—
+6K180549ZED LinkZed Technologies20180—
+6K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+6K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+6K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+6K1725133D EchoJointvue, LLC20171—
+6K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+6K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+6K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+6K153284Synaptive ImageDrive ProSynaptive Medical, Inc.201601
+6K152716EV Insite SystemPsp Corporation20160—
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—