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
73–96 of 199
Cleared Feb 04, 1992
DXS DIGITAL X-RAY SUBTRACTION
K914376
Philips Medical Systems (Cleveland), Inc.
Radiology · 126d
Cleared Jan 23, 1992
STORZ IMAGING SYSTEM
K915199
Fischer Imaging Corp.
Radiology · 65d
Cleared Nov 27, 1991
HICOR
K914313
Siemens Gammasonics, Inc.
Radiology · 65d
Cleared Aug 16, 1991
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
K913120
Siemens Medical Solutions USA, Inc.
Radiology · 32d
Cleared May 28, 1991
PHILIPS INTEGRIS V3000 AND V4000
K910370
Philips Medical Systems, Inc.
Radiology · 119d
Cleared May 15, 1991
ADVANTX AFM ANGIO SYSTEM S1808
K905653
GE Medical Systems
Radiology · 148d
Cleared Feb 04, 1991
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
K903941
Shimadzu Medical Systems
Radiology · 161d
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 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 Feb 21, 1984
ISOREX LS-36
K834496
Elscint, Inc.
Radiology · 75d
Cleared Nov 24, 1981
OMEGA II ANGIOGRAPHIC TABLE
K812913
General Electric Co.
Radiology · 36d
Cleared Nov 04, 1981
DIGITRON
K812721
Siemens Corp.
Radiology · 37d
Cleared Jun 09, 1981
PANDOROS 1200A
K811149
Siemens Corp.
Radiology · 43d