510(k) Report

Devices descending from K003266

440 later devices reach Siremobil Iso-C 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081672C-InsightMazor Surgical Technologies, Ltd.200833—
+1K061310Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc.200629—
+1K050996O-Arm Imaging SystemBreakaway Imaging, LLC2005524
+1K032280Siremobil Iso-C 3DSiemens AG200383—
+1K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc.200388—
+1K0223373D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc.200222—
+1K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001244—
+2K2538993D-AnywhereProvect.AI20260—
+2K121292Dynapbv Body SoftwareSiemens Medical Solutions USA, Inc.20120—
+2K113027Syngo Aortic Valveguide SoftwareSiemens Medical Solutions USA, Inc.2011151
+2K111052Syngo Neuro PBV-IRSiemens Medical Solutions USA, Inc.20111—
+2K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+2K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+2K092564O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton)20101618
+2K073346Ziehm Vision 2Ziehm Imaging, Inc.2008285
+2K073704I-DixelJ. Morita USA, Inc.20080—
+2K063622Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd.200711—
+2K061284I-Cat ScannerImaging Sciences Intl., Inc.2006312
+2K060344O-Arm Imaging SystemBreakaway Imaging, LLC2006511
+2K0525873D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc.200566—
+2K051980DVT ScannerImaging Sciences Intl., Inc.2005123
+2K043469Syngo Inspace 4DSiemens AG Medical Solutions2005218—
+2K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc.2004212
+2K032243Minicat DentocatXoran Technologies, Inc.200393
+3K210912Excelsius3DGlobus Medical, Inc.202110—
+3K202547Surgivisio systemSurgivisio20219—
+3K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+3K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+3K161976Ziehm Solo FDZiehm Imaging GmbH201681
+3K151000O-Arm O2 Imaging SystemMedtronic, Inc.2015157
+3K142740Ziehm Vision RFD 3DZiehm Imaging GmbH2015101
+3K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International20146—
+3K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+3K120948Prexion 3DThe Yoshida Dental Mfg. Co., Ltd.20120—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K113421MinicatXoran Technologies, Inc.201211
+3K120073Infx-8000V withToshibamedical Systems Corporation2012203
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K110911Renaissance SystemMazor Robotics, Ltd.201124—
+3K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+3K092438Ziehm SoloZiehm Imaging, Inc.200994
+3K083545Ziehm Vision RFDZiehm Imaging, Inc.2009173
+3K082410MASTER3DSE-Woo Technology20080—
+3K081847Picasso Master, Ect and Master 3DE-Woo Technology20080—
+3K0736953D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17J. Morita USA, Inc.20085—
+3K073696VeraviewepocsJ. Morita USA, Inc.200822—
+3K073350Scanora 3DSoredex Palodex Group OY200724—
+3K072574Alphard Cone Beam CT, Model X178Takara Belmont Corp.20072—
+3K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions2007210—
+3K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc.2006169—
+3K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions2006172—
+3K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+3K060328Planmeca Promax 3DPlanmeca Oy200661—
+3K053024Syngo Neuro Dsa CTSiemens AG20058—
+4K231669Ziehm Solo FDZiehm Imaging GmbH20232—
+4K231886SURGIVISIO DeviceEcential Robotics20236—
+4K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+4K220946SURGIVISIO DeviceEcential Robotics20227—
+4K220627SURGIVISIO DeviceEcential Robotics20228—
+4K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K210257Xoran Workstation, Model 10050Xoran Technologies, LLC20210—
+4K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+4K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+4K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH20201—
+4K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K202360Ziehm Vision RFD 3DZiehm Imaging GmbH20204—
+4K190064nView system 1Nview Medical, Inc.20192—
+4K183220OrthoScan TAU Mini C-ArmOrthoscan, Inc.20194—
+4K182359HipCheckStryker Corp.20181—
+4K173946ADAPT for Gamma3Stryker GmbH20182—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K173664Medtronic O-arm O2 Imaging SystemMedtronic, Inc.2017142
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International20162—
+4K161881PreXion3D ExcelsiorPrexion Corporation20162—
+4K151137X-View, ImagenEdlen Imaging, LLC20160—
+4K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+4K143435Planmed VerityPlanmed OY20152—
+4K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+4K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+4K132904Ziehm Vision RFDZiehm Imaging GmbH2013161
+4K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+4K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K121418Planmed VerityPlanmed OY20132—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K113715Lung Volume AnalysisToshibamedical Systems Corporation20120—
+4K120812RenaissanceMazor Robotics, Ltd.2012211
+4K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+4K113228Renaissance SystemMazor Robotics, Ltd.201123—
+4K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A.2011271
+4K101181Bel-CatTakara Belmont Corp.20111—
+4K110839Scanora 3DSoredex Palodex Group OY20114—
+4K111079Syngo.Via Web ViewerSiemens AG Medical Solutions20111—
+4K103689Planmeca Promax 3D MidPlanmeca Oy20110—
+4K103480Thoracic VcarGe Medical Systems, LLC20114—
+4K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY201021—