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 |
|---|---|---|---|
| Aug 25, 2009 | K092004 | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ GE Healthcare | OWB |
| Jun 29, 2009 | K091658 | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 GE Healthcare | OWB |
| May 15, 2009 | K083545 | ZIEHM VISION RFD Ziehm Imaging, Inc. | OWB |
| May 1, 2009 | K082781 | OEC 9900 ELITE Ge Healthcare Surgery | OWB |
| Mar 16, 2009 | K090590 | VERADIUS, MODEL 718-130 Philips Medical Systems North America Co. | OWB |
| Jan 22, 2009 | K083725 | RADPRO ION Virtual Imaging, Inc. | OWB |
| Dec 5, 2008 | K081073 | HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F Pausch, LLC | OWB |
| Nov 7, 2008 | K082243 | PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS General Medical Merate S.P.A | OWB |
| Aug 6, 2008 | K080847 | RFVISION, MODEL 9.9D Almana Medical Imaging | OWB |
| May 2, 2008 | K073543 | OEC 9900 ELITE Ge Oec Medical Systems | OWB |
| Aug 22, 2007 | K062623 | AXIOM LUMINOS DRF Siemens Medical Solutions USA, Inc. | OWB |
| May 18, 2007 | K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) Omega Medical Imaging, Inc. | OWB |
| Mar 9, 2007 | K070123 | TCA 5R / 5S Dornier Medtech America, Inc. | OWB |
| Oct 20, 2006 | K062647 | E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 Omega Medical Imaging, Inc. | OWB |
| Aug 15, 2006 | K061953 | 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS Ge Oec Medical Systems | OWB |
| Jul 7, 2006 | K061534 | ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM Ziehm Imaging, Inc. | OWB |
| Jun 19, 2006 | K061203 | ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM Ziehm Imaging, Inc. | OWB |
| Jun 9, 2006 | K061173 | CPIVISION DIGITAL IMAGING SYSTEM Communications & Power Industries Canada, Inc., CA | OWB |
| Jun 7, 2006 | K061163 | INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT Ge Medical Systems, LLC | OWB |
| Mar 7, 2006 | K052202 | AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc. | OWB |
| Feb 22, 2006 | K060259 | DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 Ge Medical Systems, LLC | OWB |
| Dec 22, 2005 | K053279 | UROVANTAGE Pck Electronic Industry & Trade Co., Ltd. | OWB |
| Oct 26, 2005 | K052884 | MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR Toshiba America Medical Systems, In.C | OWB |
| Sep 16, 2005 | K052412 | INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE Healthcare | OWB |
| May 26, 2005 | K051064 | ZIEHM QUANTUM Ziehm Imaging, Inc. | OWB |
| Mar 11, 2005 | K050489 | INNOVA 2100 Ge Medical Systems, LLC | OWB |
| Dec 22, 2004 | K043076 | GE OEC FLUOROSTAR Ge Oec Medical Systems, Inc. | OWB |
| Oct 29, 2004 | K042793 | ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Siemens Medi Cal Solutions, Inc. | OWB |
| Aug 26, 2004 | K042053 | INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc. | OWB |
| Aug 26, 2004 | K041931 | OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION Ge Oec Medical Systems, Inc. | OWB |
| Aug 18, 2004 | K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM Ge Oec Medical Systems, Inc. | OWB |
| Aug 11, 2004 | K041780 | NEW BRID Medical Imaging Solutions, Inc. | OWB |
| Jun 30, 2004 | K041605 | PRECISION RXI ANALOG X-RAY SYSTEM General Medical Merate S.P.A, IT | OWB |
| Jun 10, 2004 | K040675 | AXIOM ARTIS U Siemens Medical Systems, Inc. | OWB |
| May 14, 2004 | K032761 | KMC-950 C-ARM MOBILE SYSTEM United Radiology Systems, Inc. | OWB |
| Dec 9, 2003 | K033737 | ALLURA XPER FD20 Philips Medical Systems North America, Inc., NL | OWB |
| Nov 19, 2003 | K033486 | GE PRECISION MPI Nrt-Nordisk Rontgen Teknik A/S, DK | OWB |
| Oct 16, 2003 | K033244 | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION Ge Medical Systems, Inc. | OWB |
| Aug 22, 2003 | K031637 | INNOVA 3100 GE Medical Systems | OWB |
| Jul 17, 2003 | K032046 | PHILLIPS OMNIDIAGNOST ELEVA Philips Medical Systems, Inc., NL | OWB |
| May 21, 2003 | K030544 | RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM Sigma Vision, Inc. | OWB |
| Apr 7, 2003 | K030061 | PS 3000 DIGATAL PHOTOSPOT SYSTEM Precise Optics | OWB |
| Jan 16, 2003 | K024200 | INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) Ge Medical Systems, Inc. | OWB |
| Nov 26, 2002 | K023178 | INNOVA 4100 Ge Medical Systems, Inc. | OWB |
| Oct 8, 2002 | K022322 | INNOVA AND INNOVA 2000 S Ge Medical Systems, Inc. | OWB |
| Sep 17, 2002 | K022114 | IMPERIUM Elmstech, Inc. | OWB |
| Sep 17, 2002 | K022069 | OEC FLUOROTRAK 9800 PLUS Ge Oec Medical Systems | OWB |
| Apr 17, 2002 | K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems | OWB |
| Feb 12, 2002 | K012490 | ORION DIGITAL IMAGING SYSTEM Infimed, Inc. | OWB |
| Nov 15, 2001 | K013608 | DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D Toshiba America Medical Systems, In.C | OWB |
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