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
121–144 of 199
Cleared Nov 29, 1990
CATHETERIZATION C-ARM SUPPORT MH-51B(F)
K903371
Shimadzu Medical Systems
Radiology · 126d
Cleared Nov 29, 1990
CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A
K903372
Shimadzu Medical Systems
Radiology · 126d
Cleared Nov 29, 1990
CATHETERIZATION C-ARM SUPPORT MH-51C(F)
K903373
Shimadzu Medical Systems
Radiology · 126d
Cleared Oct 01, 1990
HICOR
K903375
Siemens Gammasonics, Inc.
Radiology · 67d
Cleared Aug 17, 1990
PHILIPS INTEGRIS C2000 SYSTEM
K902542
Philips Medical Systems North America, Inc.
Radiology · 72d
Cleared Mar 13, 1990
ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM)
K897115
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Aug 09, 1989
UNICATH A
K892849
Xre Corp.
Radiology · 113d
Cleared Feb 27, 1989
LC, CARDIAC POSITIONER #B5078A
K890348
General Electric Co.
Radiology · 35d
Cleared Feb 22, 1989
MULTISKOP
K890352
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Feb 16, 1989
ANGIOSTAR
K884912
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Nov 21, 1988
IMAGER
K883831
Fischer Imaging Corp.
Radiology · 73d
Cleared Nov 21, 1988
ADVANTAGE
K883860
Fischer Imaging Corp.
Radiology · 69d
Cleared Oct 31, 1988
SIEMENS PACS/I-A
K880690
Siemens Gammasonics, Inc.
Radiology · 252d
Cleared Sep 14, 1988
DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM
K883072
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Jul 01, 1988
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200
K874910
Shimadzu Precision Instruments, Inc.
Radiology · 213d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND ER-200
K875372
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20
K875373
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CEILING-SUSPENDED C-ARM CH-50
K875374
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU LATERAL C-ARM MH-30
K875375
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50B
K875376
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A
K875379
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-10
K875380
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Jan 29, 1988
UNICATH LAB
K875184
Xre Corp.
Radiology · 38d
Cleared May 06, 1985
QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM
K850455
Xre Corp.
Radiology · 89d