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 GE Medical Systems.

199
Total
199
Cleared
102d
Avg days
1978
Since
199 devices
73–96 of 199
Cleared May 07, 1996
ADVANTX LCV+
K960575
GE Medical Systems
Radiology · 85d
Cleared Dec 21, 1995
ARC SERIES
K954581
Continental X-Ray Corp.
Radiology · 80d
Cleared Dec 11, 1995
DAR-2400-15B/30B
K955395
Shimadzu Medical Systems
Radiology · 17d
Cleared Nov 20, 1995
HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
K945400
Hitachi Medical Corp. of America
Radiology · 382d
Cleared Oct 06, 1995
ANGIOREX
K954309
Toshiba Medical Systems
Radiology · 21d
Cleared Jul 03, 1995
PHILIPS EASYVISION
K952704
Philips Medical Systems, Inc.
Radiology · 19d
Cleared Feb 27, 1995
UNICATH LLU ANGIOGRAPHIC SYSTEM
K945449
Xre Corp.
Radiology · 112d
Cleared Feb 03, 1995
CEILING SUSPENDED C-ARM SUPPORT MH-100
K943545
Shimadzu Medical Systems
Radiology · 197d
Cleared Jan 30, 1995
ADVANTX LCA
K945375
GE Medical Systems
Radiology · 89d
Cleared Jan 30, 1995
DLX
K945459
General Electric Co.
Radiology · 84d
Cleared Jan 05, 1995
TOP ACOM STATION
K945293
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Dec 09, 1994
COMPAS
K945483
General Electric Co.
Radiology · 31d
Cleared Nov 07, 1994
GEMNET
K943355
GE Medical Systems
Radiology · 118d
Cleared Sep 09, 1994
CINEMAC QAS
K936002
Xre Corp.
Radiology · 268d
Cleared Aug 17, 1994
VIDEO PLUS WITH ANALYTICAL WORKSTATION
K941979
Camtronics, Ltd.
Radiology · 114d
Cleared Jul 18, 1994
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
K942120
GE Medical Systems
Radiology · 76d
Cleared Jun 06, 1994
ANGIOREX CAS-05A
K941177
Toshiba America Medical Systems, In.C
Radiology · 84d
Cleared May 20, 1994
LCA ANGIOGRAPHIC IMAGING SYSTEM
K941946
GE Medical Systems
Radiology · 29d
Cleared Apr 19, 1994
COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM
K940484
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Apr 07, 1994
DVFX, MODEL M256
K933460
Xre Corp.
Radiology · 265d
Cleared Dec 15, 1993
POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)
K933664
Siemens Gammasonics, Inc.
Radiology · 140d
Cleared Dec 13, 1993
X-RAY ANGIOGRAPHIC SYSTEM
K934496
Camtronics, Ltd.
Radiology · 89d
Cleared Nov 02, 1993
MULTI-VIEW PROCESSOR (MVP)
K931184
Adac Laboratories
Radiology · 238d
Cleared Sep 07, 1993
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
K930635
Siemens Medical Solutions USA, Inc.
Radiology · 211d