510(k) Report

Devices descending from K973598

168 later devices reach Siremobil CO2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc.2004212
+1K040675Axiom Artis USiemens Medical Systems, Inc.2004491
+1K032761KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc.200414—
+1K040066Siremobile C06Siemens Medical Solutions USA, Inc.2004212
+1K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc.200388—
+1K022114ImperiumElmstech, Inc.200215—
+1K0223373D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc.200222—
+2K202547Surgivisio systemSurgivisio20219—
+2K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemLivermoretech, Inc.20200—
+2K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+2K163140SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemGemss Medical Systems Co., Ltd.20170—
+2K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.20169—
+2K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemGemss Medical Systems Co., Ltd.20160—
+2K153244Cios FusionSiemens Medical Solutions USA, Inc.2016151
+2K153147Cios ConnectSiemens Medical Solutions USA, Inc.20160—
+2K132289Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray SystemGemss Medical Systems Co., Ltd.20140—
+2K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116—
+2K073704I-DixelJ. Morita USA, Inc.20080—
+2K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc.20079—
+2K063622Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd.200711—
+2K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc.200610—
+2K061284I-Cat ScannerImaging Sciences Intl., Inc.2006312
+2K0525873D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc.200566—
+2K051980DVT ScannerImaging Sciences Intl., Inc.2005123
+2K051133Arcadis AvanticSiemens Medical Solutions USA, Inc.200520—
+2K032243Minicat DentocatXoran Technologies, Inc.200393
+3K231886SURGIVISIO DeviceEcential Robotics20236—
+3K220946SURGIVISIO DeviceEcential Robotics20227—
+3K220627SURGIVISIO DeviceEcential Robotics20228—
+3K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+3K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+3K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+3K200218Digiscan FDXAllengers Medical Systems Limited20201—
+3K183144uMC 560iShanghai United Imaging Healthcare Co., Ltd.20190—
+3K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC20197—
+3K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201914—
+3K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+3K181767Cios SelectSiemens Medical Solutions USA, Inc.20185—
+3K180473ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR…Ecotron Co., Ltd.20180—
+3K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+3K133620Cone Beam 3D and 2D Panoramic Dental Imaging SystemImaging Sciences International20146—
+3K132094Cios AlphaSiemens Medi Cal Solutions, Inc.2014198
+3K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+3K120948Prexion 3DThe Yoshida Dental Mfg. Co., Ltd.20120—
+3K113421MinicatXoran Technologies, Inc.201211
+3K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+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—
+3K061834Xcat; Xcat for NeuroXoran Technologies, Inc.20066—
+3K060328Planmeca Promax 3DPlanmeca Oy200661—
+4K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+4K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+4K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+4K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+4K214097Explorer Air IISurgvision GmbH20222—
+4K210469Insight Agile DRFImaging Engineering, LLC20211—
+4K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC20215—
+4K210257Xoran Workstation, Model 10050Xoran Technologies, LLC20210—
+4K210307Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20211—
+4K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+4K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+4K192761Asimov-MKS Imaging SystemOnlume, Inc.20200—
+4K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20199—
+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—
+4K121418Planmed VerityPlanmed OY20132—
+4K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+4K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A.2011271
+4K101181Bel-CatTakara Belmont Corp.20111—
+4K110839Scanora 3DSoredex Palodex Group OY20114—
+4K103689Planmeca Promax 3D MidPlanmeca Oy20110—
+4K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY201021—
+4K093590Planmeca Promax 3D MaxPlanmeca Oy201015—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)Medicatech USA, Inc.20250—
+5K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.20251—
+5K241567MC2 Portable X-ray SystemOxos Medical20241—
+5K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+5K222240Explorer Air® IISurgvision GmbH20231—
+5K223409Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20220—
+5K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp.20210—
+5K212523VFSS Pro Mobile Digital Imaging SystemImagexray, LLC20211—
+5K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC20211—
+5K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+5K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+5K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+5K180918Planmed VerityPlanmed OY20181—