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 |
|---|---|---|---|
| May 4, 1995 | K946378 | BCM 400CP B C Medical , Ltd., CA | IZI |
| Feb 27, 1995 | K945449 | UNICATH LLU ANGIOGRAPHIC SYSTEM Xre Corp. | IZI |
| Feb 17, 1995 | K944952 | ANGIOGRAPHIC SYSTEM Acoma Medical Imaging, Inc. | IZI |
| Feb 3, 1995 | K943545 | CEILING SUSPENDED C-ARM SUPPORT MH-100 Shimadzu Medical Systems | IZI |
| Jan 30, 1995 | K945459 | DLX General Electric Co. | IZI |
| Jan 30, 1995 | K945375 | ADVANTX LCA GE Medical Systems | IZI |
| Jan 5, 1995 | K945293 | TOP ACOM STATION Siemens Medical Solutions USA, Inc. | IZI |
| Dec 9, 1994 | K945483 | COMPAS General Electric Co. | IZI |
| Nov 7, 1994 | K943355 | GEMNET GE Medical Systems | IZI |
| Sep 29, 1994 | K940172 | CARDIOVASCULAR MEASUREMENT SYSTEM-CMS Medis Medical Imaging Systems, Inc. | IZI |
| Sep 9, 1994 | K936002 | CINEMAC QAS Xre Corp. | IZI |
| Aug 24, 1994 | K935026 | DIGITAL MEDIA CONVERTER (D-MC) Eigen Video | IZI |
| Aug 17, 1994 | K941979 | VIDEO PLUS WITH ANALYTICAL WORKSTATION Camtronics, Ltd. | IZI |
| Jul 20, 1994 | K942503 | UNICATH FAMILY Angiographic Devices Corp. | IZI |
| Jul 18, 1994 | K942120 | ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION GE Medical Systems | IZI |
| Jun 6, 1994 | K941177 | ANGIOREX CAS-05A Toshiba America Medical Systems, In.C | IZI |
| May 20, 1994 | K941946 | LCA ANGIOGRAPHIC IMAGING SYSTEM GE Medical Systems | IZI |
| Apr 19, 1994 | K940484 | COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. | IZI |
| Apr 7, 1994 | K933460 | DVFX, MODEL M256 Xre Corp. | IZI |
| Dec 15, 1993 | K933664 | POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) Siemens Gammasonics, Inc. | IZI |
| Dec 13, 1993 | K934496 | X-RAY ANGIOGRAPHIC SYSTEM Camtronics, Ltd. | IZI |
| Dec 13, 1993 | K932410 | HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY Heartware Intl. Corp. | IZI |
| Nov 2, 1993 | K931184 | MULTI-VIEW PROCESSOR (MVP) Adac Laboratories | IZI |
| Oct 7, 1993 | K933073 | HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE Heartware Intl. Corp. | IZI |
| Sep 28, 1993 | K933058 | HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW Heartware Intl. Corp. | IZI |
| Sep 7, 1993 | K930635 | MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. | IZI |
| Jun 14, 1993 | K931170 | SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) Sony Medical Systems | IZI |
| Mar 15, 1993 | K926258 | DLX GE Medical Systems | IZI |
| Mar 2, 1993 | K925961 | OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM Diagnostic Archives, Inc. | IZI |
| Dec 30, 1992 | K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT Biodan Medical Systems, Ltd. | IZI |
| Dec 30, 1992 | K924719 | ANCOR Siemens Medical Solutions USA, Inc. | IZI |
| Dec 30, 1992 | K924708 | CINENET CARDIAC IMAGE NETWORK Sony Medical Systems | IZI |
| Dec 28, 1992 | K924137 | CSP-A (CEILING SUSPENDED POSITIONER-ANGIO) Fischer Imaging Corp. | IZI |
| Dec 17, 1992 | K924828 | BI-N Xre Corp. | IZI |
| Dec 2, 1992 | K922222 | ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. | IZI |
| Nov 20, 1992 | K923654 | POLY DIAGNOST CDX Xre Corp. | IZI |
| Oct 16, 1992 | K923813 | PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION Philips Medical Systems, Inc., NL | IZI |
| Sep 30, 1992 | K920862 | BCM-400C B C Medical , Ltd., CA | IZI |
| Sep 23, 1992 | K923112 | ANGIO-BAND Cook, Inc., CA | IZI |
| Aug 28, 1992 | K922804 | AWOS ANGIOGRAPHIC WORKSTATION Siemens Medical Solutions USA, Inc. | IZI |
| Aug 11, 1992 | K922622 | PHILIPS CARDIAC WORKSTATION Philips Medical Systems, Inc., NL | IZI |
| May 15, 1992 | K921101 | PHILIPS INTEGRIS V3000 FILM Philips Medical Systems, Inc., NL | IZI |
| Apr 27, 1992 | K920705 | POLYTRON DIGITAL IMAGING SYSTEM Siemens Medical Solutions USA, Inc. | IZI |
| Apr 13, 1992 | K920434 | ATLAS 2000 VASCULAR ROAD MAPPING SYSTEM Squires & Assoc., Inc. | IZI |
| Feb 4, 1992 | K914376 | DXS DIGITAL X-RAY SUBTRACTION Philips Medical Systems (Cleveland), Inc. | IZI |
| Jan 23, 1992 | K915199 | STORZ IMAGING SYSTEM Fischer Imaging Corp. | IZI |
| Jan 9, 1992 | K915232 | GRUNDIG ELECTRONICS VARIOUS MODELS Perkins Mfg. Co. | IZI |
| Nov 27, 1991 | K914313 | HICOR Siemens Gammasonics, Inc. | IZI |
| Nov 7, 1991 | K913685 | UNICATH EP. Xre Corp. | IZI |
| Sep 16, 1991 | K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE Advance Medical Designs, Inc. | IZI |
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