System, X-Ray, Angiographic
Regulation 892.1600
2510(k)s in 12 months (199 all time)
1recalls in 12 months (259 all time)
240recalls that name a 510(k)
Top companies in IZI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2005 | K052500 | DAR-8000F Shimadzu Medical Systems | IZI |
| Sep 2, 2005 | K052076 | DAR-8000I Shimadzu Medical Systems | IZI |
| Aug 11, 2005 | K052039 | GE OEC ALTITUDE Ge Oec Medical Systems | IZI |
| Jan 19, 2005 | K042961 | SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 Novadaq Technologies, Inc., CA | IZI |
| Oct 19, 2004 | K042646 | DYNACT Siemens Medical Systems, Inc. | IZI |
| Jul 30, 2004 | K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., NL | IZI |
| May 14, 2004 | K041027 | DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D Toshibamedical Systems Corporation | IZI |
| Apr 2, 2004 | K030139 | THE CARDIOP-B SYSTEM Paieon, Inc. | IZI |
| Feb 20, 2004 | K032443 | DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE Shimadzu Corp. | IZI |
| Dec 9, 2003 | K033184 | LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 Shimadzu Corp. | IZI |
| May 13, 2003 | K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., NL | IZI |
| Jan 24, 2003 | K023970 | QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS Medis Medical Imaging Systems BV, NL | IZI |
| Oct 30, 2002 | K023441 | PHILIPS MULTIDIAGNOST ELEVA Philips Medical Systems, NL | IZI |
| Mar 30, 2001 | K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM Siemens Medical Corp. | IZI |
| Mar 12, 2001 | K010391 | ATLAS MULTI-PURPOSE DSA SYSTEM Cares Built, Inc. | IZI |
| Nov 17, 2000 | K002840 | MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM The Phantom Laboratory, Inc. | IZI |
| Dec 21, 1999 | K993947 | KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY Siemens Corp. | IZI |
| Nov 26, 1999 | K993765 | QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) Medis Medical Imaging Systems BV | IZI |
| Nov 26, 1999 | K993763 | QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) Medis Medical Imaging Systems BV | IZI |
| Sep 1, 1999 | K991922 | DIGITAL IMAGING SYSTEM (BSR) Siemens Medical Solutions USA, Inc. | IZI |
| May 24, 1999 | K991231 | HITACHI VERSIFLEX Hitachi Medical Systems America, Inc. | IZI |
| Feb 25, 1999 | K984545 | RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS Philips Medical Systems North America, Inc., NL | IZI |
| Dec 21, 1998 | K983877 | PHILIPS INTEGRIS 3D RA OPTION Philips Medical Systems North America, Inc. | IZI |
| Jul 14, 1998 | K982203 | CAAS II LVA BIPLANE OPTION Pie Medical Equipment B.V., NL | IZI |
| Mar 23, 1998 | K974679 | THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM Medcon , Ltd., IL | IZI |
| Feb 13, 1998 | K974367 | ADVANTX LCN, ADVANTX LCLP GE Medical Systems | IZI |
| Nov 25, 1997 | K973270 | LEG'MAP OPTION Ge Medical Systems, Inc. | IZI |
| Nov 10, 1997 | K973482 | PHILIPS INTEGRIS V5000 AND BV5000 Philips Medical Systems North America, Inc. | IZI |
| Nov 4, 1997 | K972655 | CONTROL SYRINGE Medical Specialties Intl., Inc. | IZI |
| Oct 17, 1997 | K973368 | STRAIT'MAP OPTION Ge Medical Systems, Inc. | IZI |
| Oct 16, 1997 | K972229 | IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM Heartware, Inc. | IZI |
| Oct 8, 1997 | K973342 | DAR-3000B Shimadzu Corp. | IZI |
| Sep 3, 1997 | K971176 | VIEW ARCHIVING STATION Electromed Intl., Ltd., CA | IZI |
| Jul 29, 1997 | K971181 | THE MIDVIEW-MEDCON'S DICOM VIEWER Medcon , Ltd., IL | IZI |
| Jul 3, 1997 | K971489 | RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 Philips Medical Systems North America, Inc. | IZI |
| Jun 26, 1997 | K972136 | TV MONITOR (P12/17) Perkins Mfg. Co. | IZI |
| May 14, 1997 | K971365 | PHILIPS INTEGRIS H5000 Philips Medical Systems North America, Inc. | IZI |
| May 7, 1997 | K970738 | KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT Jamieson Film Co. | IZI |
| Apr 16, 1997 | K970525 | STATNET Gorca Systems, Inc. | IZI |
| Mar 12, 1997 | K955179 | CONTRAST MEDIA SET B.Braun Medical, Inc. | IZI |
| Jul 3, 1996 | K961451 | DICOMNET Lockheed Martin Communications Systems | IZI |
| May 9, 1996 | K955519 | ANALYTICAL REVIEW STATION Camtronics, Ltd. | IZI |
| May 7, 1996 | K960575 | ADVANTX LCV+ GE Medical Systems | IZI |
| Dec 21, 1995 | K954581 | ARC SERIES Continental X-Ray Corp. | IZI |
| Dec 11, 1995 | K955395 | DAR-2400-15B/30B Shimadzu Medical Systems | IZI |
| Nov 20, 1995 | K945400 | HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 Hitachi Medical Corp. of America | IZI |
| Oct 6, 1995 | K954309 | ANGIOREX Toshiba Medical Systems | IZI |
| Oct 5, 1995 | K953563 | VANGUARD XR-350 CINEANGIOGRAM PROJECTOR Jamieson Film Co. | IZI |
| Jul 3, 1995 | K952704 | PHILIPS EASYVISION Philips Medical Systems, Inc. | IZI |
| Jun 28, 1995 | K945540 | CAAS II Pie Medical Equipment B.V., NL | IZI |
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