FDA 510(k) Applications for Medical Device Product Code "OWB"

FDA 510(k) Number Applicant Device Name Decision Date
K182086 A.T.S. Applicazione Tecnologie Speciali s.r.l. ARCO FP 08/20/2019
K211777 A.T.S. Applicazione Tecnologie Speciali S.R.L. ARCO FP-S 08/13/2021
K222998 Acrew Imaging, Inc. F3 06/20/2023
K220311 Allengers Medical Systems Limited Cardiovascular Angiography System 05/03/2022
K200218 Allengers Medical Systems Limited Digiscan FDX 07/13/2020
K080847 ALMANA MEDICAL IMAGING RFVISION, MODEL 9.9D 08/06/2008
K210900 Canon Medical Systems Corporation Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 04/12/2021
K181804 Canon Medical Systems Corporation Alphenix, INFX-8000C/B, V8.0 08/02/2018
K182415 Canon Medical Systems Corporation Alphenix, INFX-8000F/B, V8.0 09/28/2018
K182546 Canon Medical Systems Corporation Alphenix, INFX-8000H/B, V8.0 10/17/2018
K203551 Canon Medical Systems Corporation Alphenix, INFX-8000V/B, /S, V9.1 12/18/2020
K181670 Canon Medical Systems Corporation Alphenix, INFX-8000V/B, V8.0 07/25/2018
K181834 Canon Medical Systems Corporation Ultimax-i, DREX-UI80 (V1.60) 07/19/2018
K181415 Canon Medical Systems Corporation XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 09/10/2018
K220342 Canon Medical Systems Corporation XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 09/27/2022
K200887 Canon, Inc. AS-10 04/15/2020
K171194 Canon, Inc. AS-10, CXDI-401RF 05/24/2017
K121444 CANON, INC. - MEDICAL EQUPMENT GROUP FLAT PANEL DETECTOR 06/07/2012
K213768 Circinus Medical Technology, LLC Bolt Navigation System 12/01/2022
K061173 COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. CPIVISION DIGITAL IMAGING SYSTEM 06/09/2006
K202431 ControlRad, Inc ControlRad Select Model Z 12/23/2020
K211782 ControlRad, Inc ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 07/01/2021
K213455 ControlRad, Inc. ControlRad Select Model Z 11/24/2021
K183109 ControlRad, Inc. ControlRad Trace Model 8 05/13/2019
K200663 ControlRad, Inc. ControlRad Trace Model 9 06/24/2020
K160088 Cydar Ltd. Cydar EV 07/07/2016
K212442 Cydar Ltd. Cydar EV (Series B) and Cydar EV Maps 12/03/2021
K070123 DORNIER MEDTECH AMERICA, INC. TCA 5R / 5S 03/09/2007
K230871 DRTECH Corporation EXTRON 5; EXTRON 7 08/17/2023
K220627 Ecential Robotics SURGIVISIO Device 03/18/2022
K220946 Ecential Robotics SURGIVISIO Device 04/15/2022
K180473 ECOTRON Co., Ltd ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR 03/23/2018
K160279 ECOTRON CO.,LTD ANYVIEW-500R Fluoroscopic Mobile X-Ray System 10/14/2016
K022114 ELMSTECH, INC. IMPERIUM 09/17/2002
K002198 FLUORO SCAN IMAGING SYSTEMS, INC. FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS 10/17/2000
K212956 FUJIFILM Corporation FDR Cross (DR-XD 3000) 11/08/2021
K974355 GE DEC MEDICAL SYSTEMS INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) 02/17/1998
K970063 GE DEC MEDICAL SYSTEMS SERIES 7600 MOBILE DIGITAL C-ARM 03/11/1997
K000221 GE DEC MEDICAL SYSTEMS SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM 04/11/2000
K963952 GE DEC MEDICAL SYSTEMS SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM 12/23/1996
K993687 GE DEC MEDICAL SYSTEMS UROVIEW 2800 12/21/1999
K092004 GE HEALTHCARE GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ 08/25/2009
K091658 GE HEALTHCARE GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 06/29/2009
K122457 GE HEALTHCARE GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS 01/02/2013
K052412 GE HEALTHCARE INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ 09/16/2005
K181403 GE Healthcare Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR 11/02/2018
K082781 GE HEALTHCARE SURGERY OEC 9900 ELITE 05/01/2009
K122234 GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC OEC 9900 ELITE 08/16/2012
K172700 GE HUALUN MEDICAL SYSTEMS CO., LTD. OEC One 11/09/2017
K031637 GE MEDICAL SYSTEMS INNOVA 3100 08/22/2003
K133278 GE MEDICAL SYSTEMS SCS DISCOVERY IGS 740 04/24/2014
K113403 GE MEDICAL SYSTEMS SCS GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM 02/14/2012
K033244 GE MEDICAL SYSTEMS, INC. DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION 10/16/2003
K024200 GE MEDICAL SYSTEMS, INC. INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) 01/16/2003
K023178 GE MEDICAL SYSTEMS, INC. INNOVA 4100 11/26/2002
K042053 GE MEDICAL SYSTEMS, INC. INNOVA 4100, INNOVA 3100 08/26/2004
K022322 GE MEDICAL SYSTEMS, INC. INNOVA AND INNOVA 2000 S 10/08/2002
K993037 GE MEDICAL SYSTEMS, INC. LCV+ VERSION 2 02/14/2000
K060259 GE MEDICAL SYSTEMS, LLC DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 02/22/2006
K050489 GE MEDICAL SYSTEMS, LLC INNOVA 2100 03/11/2005
K061163 GE MEDICAL SYSTEMS, LLC INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT 06/07/2006
K061953 GE OEC MEDICAL SYSTEMS 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS 08/15/2006
K021049 GE OEC MEDICAL SYSTEMS OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM 04/17/2002
K073543 GE OEC MEDICAL SYSTEMS OEC 9900 ELITE 05/02/2008
K022069 GE OEC MEDICAL SYSTEMS OEC FLUOROTRAK 9800 PLUS 09/17/2002
K132027 GE OEC MEDICAL SYSTEMS, INC OEC 9800 PLUS 05/01/2014
K111551 GE OEC MEDICAL SYSTEMS, INC OEC(R) 9800, OEC(R) 9800 PLUS 10/04/2011
K043076 GE OEC MEDICAL SYSTEMS, INC. GE OEC FLUOROSTAR 12/22/2004
K171565 GE OEC Medical Systems, Inc. OEC Elite 08/10/2017
K041932 GE OEC MEDICAL SYSTEMS, INC. OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM 08/18/2004
K041931 GE OEC MEDICAL SYSTEMS, INC. OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION 08/26/2004
K163140 GEMSS MEDICAL SYSTEMS CO., LTD SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System 05/26/2017
K082243 GENERAL MEDICAL MERATE S.P.A. PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS 11/07/2008
K041605 GENERAL MEDICAL MERATE S.P.A. PRECISION RXI ANALOG X-RAY SYSTEM 06/30/2004
K103425 GENORAY AMERICA INC. ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM 03/29/2011
K181943 Genoray Co., Ltd. OSCAR (OSCAR Prime, OSCAR Classic) 08/17/2018
K230787 Genoray Co., Ltd. Oscar 15 & Oscar 15i 07/20/2023
K091918 GENORAY CO., LTD. ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO 10/07/2009
K211780 Genoray Co., Ltd. ZEN-2090 Turbo 03/09/2022
K140041 GENORAY CO., LTD. ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM 11/28/2014
K172180 Genoray Co.,Ltd OSCAR 15 02/09/2018
K210912 Globus Medical Inc. Excelsius3D 08/12/2021
K212523 IMAGExRAY, LLC VFSS Pro Mobile Digital Imaging System 11/05/2021
K111344 INFIMED, INC. I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) 06/10/2011
K112180 INFIMED, INC. I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) 08/10/2011
K093066 INFIMED, INC. I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 03/16/2010
K101833 INFIMED, INC. INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 07/23/2010
K103416 INFIMED, INC. NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM 03/17/2011
K012490 INFIMED, INC. ORION DIGITAL IMAGING SYSTEM 02/12/2002
K200022 LiverMoreTech Inc. FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System 04/03/2020
K961105 MCMAHON MEDICAL SKIN DOSE MONITOR 09/05/1996
K041780 MEDICAL IMAGING SOLUTIONS, INC. NEW BRID 08/11/2004
K203281 medPhoton GmbH Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X 12/22/2020
K173664 Medtronic Inc. Medtronic O-arm O2 Imaging System 12/29/2017
K200074 Medtronic Inc. O-arm O2 Imaging System 04/24/2020
K151000 MEDTRONIC INC. O-Arm O2 Imaging System 08/06/2015
K192182 Micronica SRL C015 01/17/2020
K201172 MX Imaging, Inc. CFP-3131, CFP-2222 05/29/2020
K230185 NDR Medical Technology Pte. Ltd. ANT-X System 06/01/2023
K173631 NRT X-ray A/S Intelli-C 07/11/2018
K033486 NRT-NORDISK RONTGEN TEKNIK A/S GE PRECISION MPI 11/19/2003
K173314 NuVasive, Incorporated LessRay System 11/16/2017
K170800 NuVasive, Incorporated NuVasive LessRay with Enhanced Tracking 08/18/2017
K211064 nView medical nView s1 with nav option 10/29/2021
K221344 nView medical nView s1 with nav option 12/28/2022
K190064 nView medical, Inc. nView system 1 07/08/2019
K170752 OEC Medical Systems, Inc. OEC Elite 05/19/2017
K070834 OMEGA MEDICAL IMAGING, INC. CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) 05/18/2007
K100102 OMEGA MEDICAL IMAGING, INC. CS-SERIES-FP 08/31/2010
K062647 OMEGA MEDICAL IMAGING, INC. E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 10/20/2006
K171755 Omega Medical Imaging, LLC CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System 02/09/2018
K212336 Omega Medical Imaging, LLC Soteria.AI 11/17/2021
K120282 PAIEON, INC. CARDNAV 12/10/2012
K081073 PAUSCH LLC HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F 12/05/2008
K053279 PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. UROVANTAGE 12/22/2005
K011311 PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD UROLOGIC 07/10/2001
K203623 Philips India Limited StentBoost Mobile 04/05/2021
K170144 Philips Medical Stystems Nederland BV StentBoost Live 06/07/2017
K173433 Philips Medical Systems DMC GmbH ProxiDiagnost N90 02/05/2018
K132147 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2D PERFUSION 12/16/2013
K121772 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 03/21/2013
K133292 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; OR TABLE 03/05/2014
K130638 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURACLARITY XPER FD SERIES X-RAY SYSTEM 06/28/2013
K172307 Philips Medical Systems Nederland B.V. Dynamic Coronary Roadmap 2.0 10/24/2017
K142273 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. EmboGuide 01/30/2015
K142126 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. EP NAVIGATOR REL. 5.0 12/09/2014
K140138 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. HEARTNAVIGATOR RELEASE 2.0 06/10/2014
K132305 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. STENTBOOST REL. 4 10/30/2013
K133819 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VERADIUS 07/10/2014
K130893 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. XPERCT REL. 3 09/06/2013
K131263 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. XPERGUIDE 07/24/2013
K161839 PHILIPS MEDICAL SYSTEMS NEDERLAND BV 2D Quantitative Analysis 07/29/2016
K162859 Philips Medical Systems Nederland BV Allura Xper FD series and Allura Xper OR Table series 12/02/2016
K161563 Philips Medical Systems Nederland BV Allura Xper FD series and Allura Xper OR Table series 07/29/2016
K163715 PHILIPS MEDICAL SYSTEMS NEDERLAND BV Allura Xper R9 01/26/2017
K160455 PHILIPS MEDICAL SYSTEMS NEDERLAND BV AneurysmFlow 08/25/2016
K181830 Philips Medical Systems Nederland BV Azurion R2.0 08/02/2018
K200917 Philips Medical Systems Nederland BV Azurion R2.1 05/01/2020
K172822 Philips Medical Systems Nederland BV Azurion series R1.2 11/22/2017
K160147 PHILIPS MEDICAL SYSTEMS NEDERLAND BV CT TrueView 08/10/2016
K170130 Philips Medical Systems Nederland BV Dynamic Coronary Roadmap 06/02/2017
K151598 PHILIPS MEDICAL SYSTEMS NEDERLAND BV VesselNavigator Rel. 1.0 08/17/2015
K183101 Philips Medical Systems Nederland BV Zenition 50 12/31/2018
K183040 Philips Medical Systems Nederland BV Zenition 70 12/06/2018
K212813 Philips Medical Systems Nederland BV Zenition 70 10/01/2021
K201743 Philips Medical Systems Nederlands B.V. ClarifEye R1.0, ClarifEye Needle 02/23/2021
K181966 Philips Medical Systems Nederlands B.V. SmartPerfusion 08/17/2018
K141979 PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES 08/19/2014
K162148 PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Allura Xper R9 11/23/2016
K142708 PHILIPS MEDICAL SYSTEMS NETHRLANDS BV VERADIUS UNITY 10/22/2014
K090590 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. VERADIUS, MODEL 718-130 03/16/2009
K033737 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. ALLURA XPER FD20 12/09/2003
K102005 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. ALLURA XPER OR TABLE SERIES 08/09/2010
K983069 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PHILIPS DUO DIAGNOST 11/02/1998
K002016 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PHILIPS INTEGRIS ALLURA 09/06/2000
K010435 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS BV PULSERA/ENDURA 03/12/2001
K961374 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS MULTIDIAGNOST 4 08/19/1996
K982993 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS OMNIDIAGNOST 09/29/1998
K032046 PHILIPS MEDICAL SYSTEMS, INC. PHILLIPS OMNIDIAGNOST ELEVA 07/17/2003
K201583 Philips Medical Systems, Nederland B.V. SmartCT R1.0 02/09/2021
K960920 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. CLINIX MP 05/20/1996
K191503 Portavision Medical LLC MobileRay Pulse SE Digital Imaging System 09/04/2019
K211191 Portavision Medical LLC Virtual C DRF Digital Imaging System 06/24/2021
K212557 Portavision Medical LLC Virtual C DRF-NEO Digital Imaging System 09/24/2021
K030061 PRECISE OPTICS PS 3000 DIGATAL PHOTOSPOT SYSTEM 04/07/2003
K212159 Radiaction Ltd. Shield System 03/30/2022
K222625 Radiaction Ltd. Shield System 09/30/2022
K123226 SAFERAY SPINE, LLC LESSRAY 12/05/2012
K132970 SAFERAY SPINE, LLC LESSRAY 11/29/2013
K142243 SAFERAY SPINE, LLC LessRay with Tracking 11/18/2014
K222080 SG Healthcare CO LTD Garion Image-Intensified Fluoroscopic X-Ray System, Mobile 10/06/2022
K183144 Shanghai United Imaging Healthcare Co.,Ltd. uMC 560i 12/19/2019
K123508 Shimadzu Corporation TRINIAS 02/26/2014
K203535 Shimadzu Corporation Medical Systems Trinias 04/28/2021
K221922 Shimadzu Corporation Medical Systems Division Trinias 07/28/2022
K163286 SIEMENS MEDICAL SOLUTION USA, INC. ARTIS pheno 03/09/2017
K201156 Siemens Medical Solution USA, Inc. ARTIS pheno (VE2) 06/29/2020
K181407 Siemens Medical Solution USA, Inc. Artis zee/zeego & Artis Q/Q.zen 08/15/2018
K221281 Siemens Medical Solutions Multitom Rax 11/17/2022
K212212 Siemens Medical Solutions Multitom Rax with True2scale Body Scan Option 02/18/2022
K190768 Siemens Medical Solutions USA, Inc. ARTIS icono 09/12/2019
K193326 Siemens Medical Solutions USA, Inc. ARTIS Icono 04/16/2020
K221516 Siemens Medical Solutions USA, Inc. ARTIS icono (Ceiling Configuration) 07/19/2022
K220432 Siemens Medical Solutions USA, Inc. ARTIS icono (VE21) System 06/29/2022
K133580 SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS ONE 04/28/2014
K220409 Siemens Medical Solutions USA, Inc. ARTIS pheno (VE21) System 06/29/2022
K123529 SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM 02/26/2013
K141574 SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS ZEE/ZEEGO SW VC21 09/05/2014
K122644 SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 05/16/2013
K052202 SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM 03/07/2006
K062623 SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM LUMINOS DRF 08/22/2007
K210055 Siemens Medical Solutions USA, Inc. Cios Alpha 02/05/2021
K153147 Siemens Medical Solutions USA, Inc. Cios Connect 01/12/2016
K203504 Siemens Medical Solutions USA, Inc. Cios Flow 12/22/2020
K153244 SIEMENS MEDICAL SOLUTIONS USA, INC. Cios Fusion 03/07/2016
K153232 SIEMENS MEDICAL SOLUTIONS USA, INC. Cios Select 02/10/2016
K181767 Siemens Medical Solutions USA, Inc. Cios Select 08/17/2018
K223410 Siemens Medical Solutions USA, Inc. Cios Select (VA21) Flat Panel 12/07/2022
K210309 Siemens Medical Solutions USA, Inc. Cios Select (VA21) Flat Panel 03/05/2021
K223409 Siemens Medical Solutions USA, Inc. Cios Select (VA21) Image Intensifier 12/06/2022
K210307 Siemens Medical Solutions USA, Inc. Cios Select (VA21) Image Intensifier 03/04/2021
K181550 Siemens Medical Solutions USA, Inc. Cios Spin 10/30/2018
K152928 SIEMENS MEDICAL SOLUTIONS USA, INC. Multitom Rax 11/13/2015
K970734 SIEMENS MEDICAL SOLUTIONS USA, INC. SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS 04/21/1997
K113027 SIEMENS MEDICAL SOLUTIONS USA, INC. SYNGO AORTIC VALVEGUIDE SOFTWARE 11/22/2011
K010942 SIEMENS MEDICAL SOLUTIONS USA, INC. U04 04/12/2001
K992660 SIEMENS MEDICAL SOLUTIONS USA, INC. URF DIGITAL - OT 11/05/1999
K173639 Siemens Medical Solutions, Inc Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax 04/02/2018
K042793 SIEMENS MEDICAL SOLUTIONS, INC. ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) 10/29/2004
K132094 SIEMENS MEDICAL SOLUTIONS, INC. CIOS ALPHA 03/11/2014
K181560 Siemens Medical Systems USA, Inc. Cios Alpha 10/24/2018
K210054 Siemens Medical Systems USA, Inc. Cios Spin 02/05/2021
K040675 SIEMENS MEDICAL SYSTEMS, INC. AXIOM ARTIS U 06/10/2004
K030544 SIGMA VISION, INC. RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM 05/21/2003
K213479 Stephanix D▓RS and D▓RS 9090 12/23/2021
K221335 Stephanix D▓RS and D▓RS 9090 06/07/2022
K102529 STEPHANIX RADIOLOGICAL SYSTEMS D2RF DIGITAL DYNAMIC REMOTE SYSTEM 10/07/2010
K202547 Surgivisio Surgivisio system 03/26/2021
K171829 Therenva SAS EndoNaut 09/21/2017
K212383 Therenva SAS EndoNaut 08/31/2021
K222070 Therenva SAS EndoNaut 10/25/2022
K013608 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D 11/15/2001
K101868 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V 09/07/2010
K052884 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR 10/26/2005
K170909 Toshiba Medical Systems Coroporation Infinix INFX-8000V, V6.40 06/16/2017
K172863 Toshiba Medical Systems Corporation Infinix-i, INFX-8000V, V7.0 12/14/2017
K162614 TOSHIBA MEDICAL SYSTEMS CORPORATION Infinix, INFX-8000V, V6.35 10/17/2016
K152697 TOSHIBA MEDICAL SYSTEMS CORPORATION INFX-8000C, V6.20 01/15/2016
K120073 TOSHIBA MEDICAL SYSTEMS CORPORATION INFX-8000V WITH 01/26/2012
K143225 TOSHIBA MEDICAL SYSTEMS CORPORATION INFX-8000V with Wireless Footswitch 01/09/2015
K133535 TOSHIBA MEDICAL SYSTEMS CORPORATION INFX-8000V, V5.30 07/23/2014
K152696 Toshiba Medical Systems Corporation INFX-8000V, V6.20 01/12/2016
K143281 TOSHIBA MEDICAL SYSTEMS CORPORATION Ultimax-i 01/29/2015
K170832 Toshiba Medical Systems Corporation Ultimax-i, DREX-UI80 V1.60 07/21/2017
K142736 Toshiba Medical Systems Corporation XIDF-AWS801, Angio Workstation, v5.31 03/11/2015
K150967 Toshiba Medical Systems Corporation XIDF-AWS801, Angio Workstation, V6.10 06/18/2015
K152785 TOSHIBA MEDICAL SYSTEMS CORPORATION XIDF-AWS801, Angio Workstation, V6.20 11/25/2015
K172646 Toshiba Medical Systems Corporation XIDF-AWS801, Angio Workstation, V7.0 10/30/2017
K200360 Track X Technology, LLC TrackX 03/05/2020
K173736 TrackX Technology, LLC TrackX 02/28/2018
K982427 TREX MEDICAL CORP. TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C 09/23/1998
K032761 UNITED RADIOLOGY SYSTEMS, INC. KMC-950 C-ARM MOBILE SYSTEM 05/14/2004
K092439 VIRTUAL IMAGING, INC. CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF 11/30/2009
K093688 VIRTUAL IMAGING, INC. CANON, MODEL URS-50RF 02/04/2010
K083725 VIRTUAL IMAGING, INC. RADPRO ION 01/22/2009
K132558 VOLCANO CORPORATION SYNC-RX SYSTEM 12/12/2013
K151904 VOLCANO CORPORATION SyncVision System 07/31/2015
K190626 Volcano Corporation SyncVision System 04/12/2019
K161756 Volcano Corporation SyncVision System 09/05/2016
K172574 Volcano Corporation SyncVision System 10/05/2017
K992103 WUESTEC MEDICAL, INC. C-QUEST 09/01/1999
K221230 Xoran Technologies LLC TRON 07/28/2022
K190497 Ziehm Imaging GmbH Ziehm 8000 11/20/2019
K161976 ZIEHM IMAGING GMBH Ziehm Solo FD 10/06/2016
K193230 Ziehm Imaging GmbH Ziehm Vision FD 12/20/2019
K142740 ZIEHM IMAGING GMBH Ziehm Vision RFD 3D 04/06/2015
K202360 Ziehm Imaging GmbH Ziehm Vision RFD 3D 09/16/2020
K231701 Ziehm Imaging GmbH Ziehm Vision RFD 3D 07/10/2023
K051064 ZIEHM IMAGING, INC. ZIEHM QUANTUM 05/26/2005
K092438 ZIEHM IMAGING, INC. ZIEHM SOLO 12/23/2009
K061534 ZIEHM IMAGING, INC. ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM 07/07/2006
K061203 ZIEHM IMAGING, INC. ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM 06/19/2006
K083545 ZIEHM IMAGING, INC. ZIEHM VISION RFD 05/15/2009
K011292 ZIEHM INTERNATIONAL, INC. ZIEHM VISION 06/20/2001


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