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Panels › Radiology › Product code OWB · Class 2

Interventional Fluoroscopic X-Ray System

Regulation 892.1650

18510(k)s in 12 months (325 all time)
110recalls in 12 months (638 all time)
607recalls that name a 510(k)
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Top companies in OWB

Company510(k)sRecalls
Siemens Medical Solutions40218
Philips Medical Systems Nederland B.V.29194
Philips Electronics North America Corporation040
Philips North America034
Ziehm Imaging GmbH2112
Canon Medical System, USA, INC.024
GE Medical Systems1110
Ge Oec Medical Systems1011
GE Healthcare515
Philips Medical Systems B.V.812
Decided510(k)Device and applicantCode
Mar 23, 2018K180473ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
Ecotron Co., Ltd., KR
OWB
Feb 28, 2018K173736TrackX
Track X Technology, LLC
OWB
Feb 9, 2018K172180OSCAR 15
Genoray Co., Ltd., KR
OWB
Feb 9, 2018K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
Omega Medical Imaging, LLC
OWB
Feb 5, 2018K173433ProxiDiagnost N90
Philips Medical Systems Dmc GmbH, DE
OWB
Dec 29, 2017K173664Medtronic O-arm O2 Imaging System
Medtronic, Inc.
OWB
Dec 14, 2017K172863Infinix-i, INFX-8000V, V7.0
Toshibamedical Systems Corporation, JP
OWB
Nov 22, 2017K172822Azurion series R1.2
Philips Medical Systems Nederland B.V., NL
OWB
Nov 16, 2017K173314LessRay System
Nu Vasive, Incorporated
OWB
Nov 9, 2017K172700OEC One
Ge Hualun Medical Systems Co. , Ltd., CN
OWB
Oct 30, 2017K172646XIDF-AWS801, Angio Workstation, V7.0
Toshibamedical Systems Corporation, JP
OWB
Oct 24, 2017K172307Dynamic Coronary Roadmap 2.0
Philips Medical Systems Nederland B.V., NL
OWB
Oct 5, 2017K172574SyncVision System
Volcano Corporation
OWB
Sep 21, 2017K171829EndoNaut
Therenva Sas, FR
OWB
Aug 18, 2017K170800NuVasive LessRay with Enhanced Tracking
Nu Vasive, Incorporated
OWB
Aug 10, 2017K171565OEC Elite
Ge Oec Medical Systems, Inc.
OWB
Jul 21, 2017K170832Ultimax-i, DREX-UI80 V1.60
Toshibamedical Systems Corporation, JP
OWB
Jun 16, 2017K170909Infinix INFX-8000V, V6.40
Toshiba Medical Systems Coroporation, JP
OWB
Jun 7, 2017K170144StentBoost Live
Philips Medical Stystems Nederland BV, NL
OWB
Jun 2, 2017K170130Dynamic Coronary Roadmap
Philips Medical Systems Nederland B.V., NL
OWB
May 26, 2017K163140SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
Gemss Medical Systems Co., Ltd., KR
OWB
May 24, 2017K171194AS-10, CXDI-401RF
Canon, Inc., JP
OWB
May 19, 2017K170752OEC Elite
Oec Medical Systems, Inc.
OWB
Mar 9, 2017K163286ARTIS pheno
Siemens Medical Solution USA, Inc.
OWB
Jan 26, 2017K163715Allura Xper R9
Philips Medical Systems Nederland B.V., NL
OWB
Dec 2, 2016K162859Allura Xper FD series and Allura Xper OR Table series
Philips Medical Systems Nederland B.V., NL
OWB
Nov 23, 2016K162148Allura Xper R9
Philips Medical Systems Nethrlands BV, NL
OWB
Oct 17, 2016K162614Infinix, INFX-8000V, V6.35
Toshibamedical Systems Corporation, JP
OWB
Oct 14, 2016K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray System
Ecotron Co., Ltd., KR
OWB
Oct 6, 2016K161976Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB
Sep 5, 2016K161756SyncVision System
Volcano Corporation
OWB
Aug 25, 2016K160455AneurysmFlow
Philips Medical Systems Nederland B.V., NL
OWB
Aug 10, 2016K160147CT TrueView
Philips Medical Systems Nederland B.V., NL
OWB
Jul 29, 2016K1618392D Quantitative Analysis
Philips Medical Systems Nederland B.V., NL
OWB
Jul 29, 2016K161563Allura Xper FD series and Allura Xper OR Table series
Philips Medical Systems Nederland B.V., NL
OWB
Jul 7, 2016K160088Cydar EV
Cydar , Ltd., GB
OWB
Mar 7, 2016K153244Cios Fusion
Siemens Medical Solutions USA, Inc.
OWB
Feb 10, 2016K153232Cios Select
Siemens Medical Solutions USA, Inc.
OWB
Jan 15, 2016K152697INFX-8000C, V6.20
Toshibamedical Systems Corporation, JP
OWB
Jan 12, 2016K153147Cios Connect
Siemens Medical Solutions USA, Inc.
OWB
Jan 12, 2016K152696INFX-8000V, V6.20
Toshibamedical Systems Corporation, JP
OWB
Nov 25, 2015K152785XIDF-AWS801, Angio Workstation, V6.20
Toshibamedical Systems Corporation, JP
OWB
Nov 13, 2015K152928Multitom Rax
Siemens Medical Solutions USA, Inc.
OWB
Aug 17, 2015K151598VesselNavigator Rel. 1.0
Philips Medical Systems Nederland B.V., NL
OWB
Aug 6, 2015K151000O-Arm O2 Imaging System
Medtronic, Inc.
OWB
Jul 31, 2015K151904SyncVision System
Volcano Corporation
OWB
Jun 18, 2015K150967XIDF-AWS801, Angio Workstation, V6.10
Toshibamedical Systems Corporation, JP
OWB
Apr 6, 2015K142740Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Mar 11, 2015K142736XIDF-AWS801, Angio Workstation, v5.31
Toshibamedical Systems Corporation, JP
OWB
Jan 30, 2015K142273EmboGuide
Philips Medical Systems Nederland B.V., NL
OWB

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