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 |
| K250282 | A.T.S. Applicazione Tecnologie Speciali s.r.l. | Persona C HR | 04/30/2025 |
| 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 |
| K240199 | Alphatec Spine, Inc. | IntraOp Alignment System | 05/22/2024 |
| K243432 | Brainlab AG | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | 07/22/2025 |
| K232298 | Canon Inc. | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | 04/26/2024 |
| 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 |
| K233107 | Canon Medical Systems Corporation | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | 08/30/2024 |
| 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 |
| K243884 | Caranx Medical | TAVIPILOT | 07/07/2025 |
| 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 |
| K250010 | DRTECH Corporation | EXTRON 3; EXTRON 5; EXTRON 7 | 06/10/2025 |
| 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 |
| K233230 | Epica International, Inc. | See Factor CT3Ö | 06/21/2024 |
| 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 |
| K243446 | GE Medical Systems SCS | 3DXR | 02/25/2025 |
| K232344 | GE Medical Systems SCS | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | 10/11/2023 |
| 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 |
| K233200 | Gemss Healthcare Co., Ltd. | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | 11/16/2023 |
| 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 |
| K242731 | Medicatech USA Inc. | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | 05/16/2025 |
| K234067 | medPhoton GmbH | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | 03/28/2025 |
| 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 |
| K240465 | Medtronic Navigation, Inc | O-arm O2 Imaging System | 06/21/2024 |
| K192182 | Micronica SRL | C015 | 01/17/2020 |
| K201172 | MX Imaging, Inc. | CFP-3131, CFP-2222 | 05/29/2020 |
| K243411 | Nanjing Perlove Medical Equipment Co., Ltd. | Diagnostic X-ray System | 05/19/2025 |
| 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 |
| K241567 | Oxos Medical | MC2 Portable X-ray System | 12/06/2024 |
| 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 |
| K232420 | Philips Medical Systems Nederland BV | Zenition 30 | 02/16/2024 |
| 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 |
| K240224 | Philips Medical Systems Nederlands B.V. | Zenition 90 | 05/22/2024 |
| 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 |
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| K002016 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. | PHILIPS INTEGRIS ALLURA | 09/06/2000 |
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| 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 |
| K243376 | Shanghai United Imaging Healthcare Co.,Ltd. | uAngio AVIVA CX | 04/28/2025 |
| K183144 | Shanghai United Imaging Healthcare Co.,Ltd. | uMC 560i | 12/19/2019 |
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| K181407 | Siemens Medical Solution USA, Inc. | Artis zee/zeego & Artis Q/Q.zen | 08/15/2018 |
| K250660 | Siemens Medical Solutions | LUMINOS Q.namix T; LUMINOS Q.namix R | 07/14/2025 |
| K221281 | Siemens Medical Solutions | Multitom Rax | 11/17/2022 |
| K212212 | Siemens Medical Solutions | Multitom Rax with True2scale Body Scan Option | 02/18/2022 |
| K241572 | Siemens Medical Solutions USA, Inc | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) | 10/22/2024 |
| K233748 | Siemens Medical Solutions USA, Inc | CIARTIC Move (VB10) | 03/15/2024 |
| K251520 | Siemens Medical Solutions USA, Inc | Cios Alpha; Cios Flow | 07/09/2025 |
| 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 |
| K230950 | Siemens Medical Solutions USA, Inc. | ARTIS icono (VE30A) | 12/14/2023 |
| K133580 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ARTIS ONE | 04/28/2014 |
| K220409 | Siemens Medical Solutions USA, Inc. | ARTIS pheno (VE21) System | 06/29/2022 |
| K230949 | Siemens Medical Solutions USA, Inc. | ARTIS pheno (VE30A) | 12/15/2023 |
| 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 |
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