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 Precision Instruments, Inc..

199
Total
199
Cleared
102d
Avg days
1978
Since
199 devices
25–48 of 199
Cleared Mar 02, 2012
C-THV SYSTEM
K113594
Paieon, Inc.
Radiology · 88d
Cleared Dec 13, 2011
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
K113034
Ge Healthcare
Radiology · 63d
Cleared Jul 26, 2011
INTEGRATED INNOVA - S5I SYSTEM OPTION
K111209
Ge Healthcare
Radiology · 88d
Cleared May 27, 2011
THE IC-PRO SYSTEM
K110256
Paieon, Inc.
Radiology · 119d
Cleared Jun 18, 2009
ARTIS ZEE / ZEEGOS WITH SW VC14
K090745
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Feb 11, 2008
ARTIS ZEE AND ZEEGO
K073290
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Aug 31, 2007
DAR-9400F
K072006
Shimadzu Corp.
Radiology · 39d
Cleared Jul 05, 2007
GE OEC ALTITUDE
K071717
Shimadzu Corp.
Radiology · 13d
Cleared Oct 05, 2006
BRANSIST SAFIRE
K062360
Shimadzu Corp.
Radiology · 52d
Cleared Apr 04, 2006
XPERCT
K060749
Philips Medical Systems North America Co.
Radiology · 15d
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 Aug 11, 2005
GE OEC ALTITUDE
K052039
Ge Oec Medical Systems
Radiology · 14d
Cleared Jan 19, 2005
SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
K042961
Novadaq Technologies, Inc.
Radiology · 84d
Cleared Oct 19, 2004
DYNACT
K042646
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Jul 30, 2004
ALLURA XPER FD10
K041949
Philips Medical Systems North America Co.
Radiology · 10d
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 Jan 24, 2003
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
K023970
Medis Medical Imaging Systems BV
Radiology · 56d
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 Nov 26, 1999
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
K993763
Medis Medical Imaging Systems BV
Radiology · 18d