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
97–120 of 199
Cleared Mar 15, 1993
DLX
K926258
GE Medical Systems
Radiology · 87d
Cleared Dec 30, 1992
ANCOR
K924719
Siemens Medical Solutions USA, Inc.
Radiology · 100d
Cleared Dec 30, 1992
CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT
K926082
Biodan Medical Systems, Ltd.
Radiology · 29d
Cleared Dec 28, 1992
CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)
K924137
Fischer Imaging Corp.
Radiology · 132d
Cleared Dec 17, 1992
BI-N
K924828
Xre Corp.
Radiology · 80d
Cleared Dec 02, 1992
ANGIOGRAPHIC X-RAY SYSTEM
K922222
Siemens Medical Solutions USA, Inc.
Radiology · 204d
Cleared Nov 20, 1992
POLY DIAGNOST CDX
K923654
Xre Corp.
Radiology · 122d
Cleared Oct 16, 1992
PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION
K923813
Philips Medical Systems, Inc.
Radiology · 79d
Cleared Sep 23, 1992
ANGIO-BAND
K923112
Cook, Inc.
Radiology · 90d
Cleared Aug 28, 1992
AWOS ANGIOGRAPHIC WORKSTATION
K922804
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Aug 11, 1992
PHILIPS CARDIAC WORKSTATION
K922622
Philips Medical Systems, Inc.
Radiology · 69d
Cleared May 15, 1992
PHILIPS INTEGRIS V3000 FILM
K921101
Philips Medical Systems, Inc.
Radiology · 67d
Cleared Apr 27, 1992
POLYTRON DIGITAL IMAGING SYSTEM
K920705
Siemens Medical Solutions USA, Inc.
Radiology · 69d
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 Nov 07, 1991
UNICATH EP.
K913685
Xre Corp.
Radiology · 80d
Cleared Sep 16, 1991
ADVANCE DISPOSABLE CONTROL SYRINGE
K911732
Advance Medical Designs, Inc.
Radiology · 152d
Cleared Aug 28, 1991
ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM
K912416
Xre Corp.
Radiology · 89d
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 Mar 26, 1991
NAMIC CONTRAST SAVINGS DELIVERY SYSTEM
K903493
North American Instrument Corp.
Radiology · 235d
Cleared Feb 04, 1991
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400
K903941
Shimadzu Medical Systems
Radiology · 161d