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
+6K150420Centricity Universal ViewerGE Healthcare2015315
+6K141561VM Pacs with VM Medical WorkstationVisual Medica20150—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,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—
+6K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+6K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+6K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+6K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+6K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare201368
+6K123575MammoworkstationImage Diagnost International GmbH20132—
+6K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH20110—
+6K101342Osirix MDPixmeo Sarl201044—
+6K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081—
+6K073176Kanteron Dicom Station (KDS), Model 3.0Monica Veytia20080—
+7K253884Koios DS (3.8)Koios Medical, Inc.20260—
+7K261519Sonio SuspectSonio20260—
+7K252294Fetal EchoScan (v1.2)Brightheart20250—
+7K251030Sirona Advanced Imaging SuiteSirona Medical20250—
+7K250484PIUR tUS insidePiur Imaging GmbH20250—
+7K251071Fetal EchoScan (v1.1)Brightheart20251—
+7K242838QuickRadAikenist Technologies Pvt, Ltd.20250—
+7K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+7K232891Carpl (Carpl)Carpl Ai, Inc.20242—
+7K232589Horos MD™Icat Solutions, Ltd.20241—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+7K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+7K231360Ambra PACSDicom Grid Dba Ambra Health202301
+7K222275Saige-DensityDeepHealth, Inc.20221—
+7K212565CoverScan v1Perspectum, Ltd.20221—
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+7K2116563D Echo v1.1Jointvue, LLC20210—
+7K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+7K201092LSNImaging Biometrics, LLC20200—
+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—
+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—
+7K182419Centricity Universal ViewerGE Healthcare201828
+7K181962CubeVueCurvebeam, LLC20180—
+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—
+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—
+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
+7K150976CollageAnatomage, Inc.20150—
+7K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+7K143361Mammo WorkstationGE Healthcare20151—
+7K141881RapidresultsRamsoft, Inc.20145—
+7K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+7K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+8K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)20260—
+8K253008maiLinkMaihub Corp.20260—
+8K250955XC11 ICE System, USAYorlabs, Inc.20250—
+8K242552Horos MobileIcat Solutions, Ltd.20250—
+8K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+8K241561MammoScreen BDTherapixel20241—
+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—
+8K230294CoverScan (CoverScan v1.1)Perspectum20230—
+8K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+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—
+8K211312Universal ViewerGE Healthcare202112
+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—
+8K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+8K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+8K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+8K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+8K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+8K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—