IZI · Class II · 21 CFR 892.1600

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

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

199
Total
199
Cleared
102d
Avg days
1978
Since
199 devices
25–48 of 199
Cleared Oct 05, 2006
BRANSIST SAFIRE
K062360
Shimadzu Corp.
Radiology · 52d
Cleared Oct 17, 2005
DAR-8000F
K052500
Shimadzu Medical Systems
Radiology · 34d
Cleared Sep 02, 2005
DAR-8000I
K052076
Shimadzu Medical Systems
Radiology · 32d
Cleared May 14, 2004
DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D
K041027
Toshibamedical Systems Corporation
Radiology · 23d
Cleared Feb 20, 2004
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
K032443
Shimadzu Corp.
Radiology · 196d
Cleared Dec 09, 2003
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
K033184
Shimadzu Corp.
Radiology · 69d
Cleared May 13, 2003
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
K031333
Philips Medical Systems North America, Inc.
Radiology · 15d
Cleared Oct 30, 2002
PHILIPS MULTIDIAGNOST ELEVA
K023441
Philips Medical Systems
Radiology · 15d
Cleared Dec 21, 1999
KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY
K993947
Siemens Corp.
Radiology · 29d
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 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 Oct 17, 1997
STRAIT'MAP OPTION
K973368
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Oct 08, 1997
DAR-3000B
K973342
Shimadzu Corp.
Radiology · 33d
Cleared Jul 03, 1997
RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
K971489
Philips Medical Systems North America, Inc.
Radiology · 71d
Cleared May 14, 1997
PHILIPS INTEGRIS H5000
K971365
Philips Medical Systems North America, Inc.
Radiology · 30d
Cleared Mar 12, 1997
CONTRAST MEDIA SET
K955179
B.Braun Medical, Inc.
Radiology · 485d
Cleared May 07, 1996
ADVANTX LCV+
K960575
GE Medical Systems
Radiology · 85d
Cleared Dec 11, 1995
DAR-2400-15B/30B
K955395
Shimadzu Medical Systems
Radiology · 17d
Cleared Oct 06, 1995
ANGIOREX
K954309
Toshiba Medical Systems
Radiology · 21d