510(k) Report

Devices descending from K003266

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K093590Planmeca Promax 3D MaxPlanmeca Oy201015—
+4K083227Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc.200849—
+4K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+4K063507Syngo Neuro PBV CTSiemens AG20060—
+5K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+5K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20251—
+5K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version…Medphoton GmbH20250—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K241440HealthCCSngNano-X AI, Ltd.20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K234109Ziehm Solo FDZiehm Imaging GmbH202411
+5K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K230045HipCheckStryker Corp.20230—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K231701Ziehm Vision RFD 3DZiehm Imaging GmbH202331
+5K230112CAC SoftwareImbio, Inc.20230—
+5K230223iCAC DeviceBunkerhill, Inc.20236—
+5K223071Xenoview VDPPolarean, Inc.20220—
+5K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K203783ClariPulmoClaripi, Inc.20220—
+5K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+5K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.20210—
+5K211064nView s1 with nav optionNview Medical20211—
+5K213113Orthoscan Tau Mini C-ArmOrthoscan, Inc.20213—
+5K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203428Ziehm Vision RFDZiehm Imaging GmbH20213—
+5K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+5K200990VIDAvisionVida Diagnostics, Inc.20202—
+5K200218Digiscan FDXAllengers Medical Systems Limited20201—
+5K200074O-arm O2 Imaging SystemMedtronic, Inc.202013—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K191550BroncholabFluidda, Inc.20200—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+5K180918Planmed VerityPlanmed OY20181—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+5K173821LungQ SoftwareThirona Corporation20183—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173878PreXion3D ExcelsiorPrexion Corporation20181—
+5K163423Orthopantomograph OP300Palodex Group OY201721
+5K160140DENTRIa seriesHdx Will Corp.20169—
+5K160723OnSight 3D Extremity SystemCarestream Health, Inc.20161—
+5K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy20167—
+5K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+5K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+5K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+5K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+5K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+5K123332Naomi-CTLk Consulting Group20130—
+5K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+5K130443I-Max Touch 3DOwandy201321
+5K130297Scanora 3DXPalodex Group OY20130—
+5K122981Rayscan a-Expert 3DRay Co., Ltd.201324—
+5K122806Image Works PanouraMic International20132—
+5K122018OP300Palodex Group OY20128—
+5K121449DirectpathCybernet Systems Co., Ltd.20120—
+5K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+5K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd.201111—
+5K093810BF-NaviKgt, Inc.20101—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20260—
+6K252249Extremity CT Imaging SystemMars Bioimaging, Ltd.20260—
+6K260166Bunkerhill Contrast CACBunkerHill Health20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K250662Bunkerhill MACBunkerHill Health20250—
+6K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.20251—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K243646Ziehm Solo FDZiehm Imaging GmbH20250—
+6K243229Bunkerhill AVCBunkerHill Health20253—
+6K243303Ziehm Vision RFD 3DZiehm Imaging GmbH20252—
+6K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.202521