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
+6K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+6K201092LSNImaging Biometrics, LLC20200—
+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—
+6K182419Centricity Universal ViewerGE Healthcare201828
+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—
+6K181962CubeVueCurvebeam, LLC20180—
+6K1808835D ViewerSamsung Medison Co., Ltd.20180—
+6K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+6K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+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—
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+6K150976CollageAnatomage, Inc.20150—
+6K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+6K143361Mammo WorkstationGE Healthcare20151—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+6K141881RapidresultsRamsoft, Inc.20145—
+6K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+6K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+6K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+6K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+6K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+7K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+7K253884Koios DS (3.8)Koios Medical, Inc.20260—
+7K261519Sonio SuspectSonio20260—
+7K253008maiLinkMaihub Corp.20260—
+7K252294Fetal EchoScan (v1.2)Brightheart20250—
+7K250484PIUR tUS insidePiur Imaging GmbH20250—
+7K251071Fetal EchoScan (v1.1)Brightheart20251—
+7K242552Horos MobileIcat Solutions, Ltd.20250—
+7K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+7K241561MammoScreen BDTherapixel20241—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K230294CoverScan (CoverScan v1.1)Perspectum20230—
+7K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K2116563D Echo v1.1Jointvue, LLC20210—
+7K211312Universal ViewerGE Healthcare202112
+7K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+7K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+7K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+7K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+7K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+7K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+7K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+7K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+7K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+7K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+7K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+7K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.20160—
+7K160937SenolrisGE Healthcare20160—
+7K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+7K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+7K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+7K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+7K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+8K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+8K253639ViewGE Healthcare20260—
+8K250955XC11 ICE System, USAYorlabs, Inc.20250—
+8K243685MammoScreen BDTherapixel20250—
+8K243509Archer PSI System3D-Side20250—
+8K241546aiCockpit AI ViewerFovia, Inc.20250—
+8K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+8K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+8K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+8K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+8K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+8K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+8K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—