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)
Top companies in OWB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2015 | K143281 | Ultimax-i Toshibamedical Systems Corporation, JP | OWB |
| Jan 9, 2015 | K143225 | INFX-8000V with Wireless Footswitch Toshibamedical Systems Corporation, JP | OWB |
| Dec 9, 2014 | K142126 | EP NAVIGATOR REL. 5.0 Philips Medical Systems Nederland B.V., NL | OWB |
| Nov 28, 2014 | K140041 | ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM Genoray Co., Ltd. | OWB |
| Nov 18, 2014 | K142243 | LessRay with Tracking Saferay Spine, LLC | OWB |
| Oct 22, 2014 | K142708 | VERADIUS UNITY Philips Medical Systems Nethrlands BV, NL | OWB |
| Sep 5, 2014 | K141574 | ARTIS ZEE/ZEEGO SW VC21 Siemens Medical Solutions USA, Inc. | OWB |
| Aug 19, 2014 | K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, NL | OWB |
| Jul 23, 2014 | K133535 | INFX-8000V, V5.30 Toshibamedical Systems Corporation | OWB |
| Jul 10, 2014 | K133819 | VERADIUS Philips Medical Systems Nederland B.V., NL | OWB |
| Jun 10, 2014 | K140138 | HEARTNAVIGATOR RELEASE 2.0 Philips Medical Systems Nederland B.V. | OWB |
| May 1, 2014 | K132027 | OEC 9800 PLUS Ge Oec Medical Systems, Inc. | OWB |
| Apr 28, 2014 | K133580 | ARTIS ONE Siemens Medical Solutions USA, Inc. | OWB |
| Apr 24, 2014 | K133278 | DISCOVERY IGS 740 GE Medical Systems SCS, FR | OWB |
| Mar 11, 2014 | K132094 | CIOS ALPHA Siemens Medi Cal Solutions, Inc. | OWB |
| Mar 5, 2014 | K133292 | ALLURA XPER FD; OR TABLE Philips Medical Systems Nederland B.V., NL | OWB |
| Feb 26, 2014 | K123508 | TRINIAS Shimadzu Corporation, JP | OWB |
| Dec 16, 2013 | K132147 | 2D PERFUSION Philips Medical Systems Nederland B.V., NL | OWB |
| Dec 12, 2013 | K132558 | SYNC-RX SYSTEM Volcano Corporation | OWB |
| Nov 29, 2013 | K132970 | LESSRAY Saferay Spine, LLC | OWB |
| Oct 30, 2013 | K132305 | STENTBOOST REL. 4 Philips Medical Systems Nederland B.V., NL | OWB |
| Sep 6, 2013 | K130893 | XPERCT REL. 3 Philips Medical Systems Nederland B.V., NL | OWB |
| Jul 24, 2013 | K131263 | XPERGUIDE Philips Medical Systems Nederland B.V., NL | OWB |
| Jun 28, 2013 | K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Philips Medical Systems Nederland B.V., NL | OWB |
| May 16, 2013 | K122644 | ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 Siemens Medical Solutions USA, Inc. | OWB |
| Mar 21, 2013 | K121772 | ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 Philips Medical Systems Nederland B.V., NL | OWB |
| Feb 26, 2013 | K123529 | ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc. | OWB |
| Jan 2, 2013 | K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE Healthcare, FR | OWB |
| Dec 10, 2012 | K120282 | CARDNAV Paieon, Inc., IL | OWB |
| Dec 5, 2012 | K123226 | LESSRAY Saferay Spine, LLC | OWB |
| Aug 16, 2012 | K122234 | OEC 9900 ELITE Ge Healthcare Surgery GE Oec Medical Systems, Inc. | OWB |
| Jun 7, 2012 | K121444 | FLAT PANEL DETECTOR Canon, Inc. - Medical Equpment Group | OWB |
| Feb 14, 2012 | K113403 | GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM GE Medical Systems SCS, FR | OWB |
| Jan 26, 2012 | K120073 | INFX-8000V WITH Toshibamedical Systems Corporation | OWB |
| Nov 22, 2011 | K113027 | SYNGO AORTIC VALVEGUIDE SOFTWARE Siemens Medical Solutions USA, Inc. | OWB |
| Oct 4, 2011 | K111551 | OEC(R) 9800, OEC(R) 9800 PLUS Ge Oec Medical Systems, Inc. | OWB |
| Aug 10, 2011 | K112180 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) Infimed, Inc. | OWB |
| Jun 10, 2011 | K111344 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) Infimed, Inc. | OWB |
| Mar 29, 2011 | K103425 | ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM Genoray America, Inc. | OWB |
| Mar 17, 2011 | K103416 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM Infimed, Inc. | OWB |
| Oct 7, 2010 | K102529 | D2RF DIGITAL DYNAMIC REMOTE SYSTEM Stephanix Radiological Systems | OWB |
| Sep 7, 2010 | K101868 | INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Toshiba America Medical Systems, In.C | OWB |
| Aug 31, 2010 | K100102 | CS-SERIES-FP Omega Medical Imaging, Inc. | OWB |
| Aug 9, 2010 | K102005 | ALLURA XPER OR TABLE SERIES Philips Medical Systems North America, Inc. | OWB |
| Jul 23, 2010 | K101833 | INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 Infimed, Inc. | OWB |
| Mar 16, 2010 | K093066 | I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 Infimed, Inc. | OWB |
| Feb 4, 2010 | K093688 | CANON, MODEL URS-50RF Virtual Imaging, Inc. | OWB |
| Dec 23, 2009 | K092438 | ZIEHM SOLO Ziehm Imaging, Inc. | OWB |
| Nov 30, 2009 | K092439 | CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF Virtual Imaging, Inc. | OWB |
| Oct 7, 2009 | K091918 | ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO Genoray Co., Ltd. | OWB |
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