IZI · Class II · 21 CFR 892.1600

FDA Product Code IZI: System, X-ray, Angiographic

Leading manufacturers include Siemens Medical Solutions USA, Inc., Xre Corp. and Shimadzu Medical Systems.

199
Total
199
Cleared
102d
Avg days
1978
Since
199 devices
49–72 of 199
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
K993765
Medis Medical Imaging Systems BV
Radiology · 18d
Cleared Sep 01, 1999
DIGITAL IMAGING SYSTEM (BSR)
K991922
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared May 24, 1999
HITACHI VERSIFLEX
K991231
Hitachi Medical Systems America, Inc.
Radiology · 42d
Cleared Feb 25, 1999
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
K984545
Philips Medical Systems North America, Inc.
Radiology · 65d
Cleared Dec 21, 1998
PHILIPS INTEGRIS 3D RA OPTION
K983877
Philips Medical Systems North America, Inc.
Radiology · 49d
Cleared Jul 14, 1998
CAAS II LVA BIPLANE OPTION
K982203
Pie Medical Equipment B.V.
Radiology · 22d
Cleared Mar 23, 1998
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
K974679
Medcon , Ltd.
Radiology · 98d
Cleared Feb 13, 1998
ADVANTX LCN, ADVANTX LCLP
K974367
GE Medical Systems
Radiology · 85d
Cleared Nov 25, 1997
LEG'MAP OPTION
K973270
Ge Medical Systems, Inc.
Radiology · 84d
Cleared Nov 10, 1997
PHILIPS INTEGRIS V5000 AND BV5000
K973482
Philips Medical Systems North America, Inc.
Radiology · 56d
Cleared Nov 04, 1997
CONTROL SYRINGE
K972655
Medical Specialties Intl., Inc.
Radiology · 112d
Cleared Oct 17, 1997
STRAIT'MAP OPTION
K973368
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Oct 16, 1997
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
K972229
Heartware, Inc.
Radiology · 125d
Cleared Oct 08, 1997
DAR-3000B
K973342
Shimadzu Corp.
Radiology · 33d
Cleared Sep 03, 1997
VIEW ARCHIVING STATION
K971176
Electromed Intl., Ltd.
Radiology · 156d
Cleared Jul 29, 1997
THE MIDVIEW-MEDCON'S DICOM VIEWER
K971181
Medcon , Ltd.
Radiology · 120d
Cleared Jul 03, 1997
RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
K971489
Philips Medical Systems North America, Inc.
Radiology · 71d
Cleared Jun 26, 1997
TV MONITOR (P12/17)
K972136
Perkins Mfg. Co.
Radiology · 20d
Cleared May 14, 1997
PHILIPS INTEGRIS H5000
K971365
Philips Medical Systems North America, Inc.
Radiology · 30d
Cleared May 07, 1997
KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
K970738
Jamieson Film Co.
Radiology · 68d
Cleared Apr 16, 1997
STATNET
K970525
Gorca Systems, Inc.
Radiology · 64d
Cleared Mar 12, 1997
CONTRAST MEDIA SET
K955179
B.Braun Medical, Inc.
Radiology · 485d
Cleared Jul 03, 1996
DICOMNET
K961451
Lockheed Martin Communications Systems
Radiology · 78d
Cleared May 09, 1996
ANALYTICAL REVIEW STATION
K955519
Camtronics, Ltd.
Radiology · 157d