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
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K111660Xelis CardiacInfinitt Co., Ltd.20110—
+4K111613Xelis FusionInfinitt Co., Ltd.20110—
+4K103130Xelis 3DInfinitt Co., Ltd.20110—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K100837Pacentric Connect, Traveler and WebFimreite Software AS20100—
+4K102684Xelis DentalInfinitt Co., Ltd.20102—
+4K092328Med-Seg, Model BTMS 1000Bartron Medical Imaging, Inc.20100—
+4K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+4K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+4K081630Mammo WorkstationImage Diagnost International GmbH20084—
+4K081469Sectra Workstation, IDS7 Version 11.3, IDS5 Version 11.1 P2Sectra Imtec AB20080—
+4K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+4K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+4K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH200749—
+5K261874Syneris PACS v.1.0.1.0Syneris20260—
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K251484CT:VQ4Dmedical Limited20250—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K222781AugmentoDeeptek Medical Imaging Private Limited20234—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K212616Koios DSKoios Medical, Inc.20214—
+5K203785ClariSIGMAMClaripi, Inc.20210—
+5K203555AmCAD-UTAmcad Biomed Corporation20212—
+5K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K201411Visage Breast DensityVisage Imaging GmbH20210—
+5K201555EchoGo ProUltromics, Ltd.20206—
+5K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+5K200822BraidBraid.Health20201—
+5K201296i-Rapha SolutionIrm, Inc.20200—
+5K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+5K192973densitas densityaiDensitas, Inc.20205—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+5K173574DenSeeMammoStatlife20180—
+5K180549ZED LinkZed Technologies20180—
+5K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+5K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+5K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K1619555D ViewerSamsung Medison Co., Ltd.20163—
+5K153284Synaptive ImageDrive ProSynaptive Medical, Inc.201601
+5K152716EV Insite SystemPsp Corporation20160—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+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—
+5K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K150420Centricity Universal ViewerGE Healthcare2015315
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K141561VM Pacs with VM Medical WorkstationVisual Medica20150—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+5K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+5K123575MammoworkstationImage Diagnost International GmbH20132—
+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—
+5K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH20110—
+5K101342Osirix MDPixmeo Sarl201044—
+5K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081—
+5K073176Kanteron Dicom Station (KDS), Model 3.0Monica Veytia20080—
+6K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+6K251030Sirona Advanced Imaging SuiteSirona Medical20250—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K243614Sonio SuspectSonio20251—
+6K242838QuickRadAikenist Technologies Pvt, Ltd.20250—
+6K242130Koios DSKoios Medical, Inc.20241—
+6K242342Fetal EchoScanBrightheart20242—
+6K241245EchoSolv ASEcho IQ, Ltd.20240—
+6K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+6K234141AISAP Cardio V1.0Aisap20240—
+6K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+6K232891Carpl (Carpl)Carpl Ai, Inc.20242—
+6K232589Horos MD™Icat Solutions, Ltd.20241—
+6K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+6K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+6K231360Ambra PACSDicom Grid Dba Ambra Health202301
+6K222275Saige-DensityDeepHealth, Inc.20221—
+6K212565CoverScan v1Perspectum, Ltd.20221—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+6K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—