IZO · Class I · 21 CFR 892.1700

FDA Product Code IZO: Generator, High-voltage, X-ray, Diagnostic

Leading manufacturers include Fischer Imaging Corp., General Electric Co. and Shimadzu Medical Systems.

163
Total
163
Cleared
75d
Avg days
1976
Since
163 devices
73–96 of 163
Cleared Feb 26, 1991
HFQ SERIES CONTROLS AND GENERATORS
K905799
Bennett X-Ray Corp.
Radiology · 88d
Cleared Feb 19, 1991
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
K904169
Varian Canada, Inc.
Radiology · 161d
Cleared Feb 13, 1991
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
K902986
Electromek Diagnostic Systems, Inc.
Radiology · 232d
Cleared Feb 13, 1991
VPW2877E7 X RAY POWER SUPPLY
K905855
Varian Canada, Inc.
Radiology · 54d
Cleared Jan 03, 1991
ANATECH X-RAY GENERATOR
K904114
Continental X-Ray Corp.
Radiology · 119d
Cleared Dec 26, 1990
G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS
K902987
Electromek Diagnostic Systems, Inc.
Radiology · 183d
Cleared Dec 19, 1990
G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN
K902985
Electromek Diagnostic Systems, Inc.
Radiology · 176d
Cleared Dec 19, 1990
G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
K902988
Electromek Diagnostic Systems, Inc.
Radiology · 176d
Cleared Nov 29, 1990
KXO-80C/80D
K904043
Toshiba America Medical Systems, In.C
Radiology · 86d
Cleared Nov 13, 1990
TEC 1410
K904397
Bay Shore Medical Equipment Corp.
Radiology · 49d
Cleared Oct 03, 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
K903942
Shimadzu Medical Systems
Radiology · 37d
Cleared Aug 10, 1990
VPW 2877D5, X-RAY POWER SUPPLY
K902106
Varian Assoc., Inc.
Radiology · 94d
Cleared Aug 03, 1990
FUTURUS 2001 X-RAY GENERATOR
K902637
Acoma Medical Imaging, Inc.
Radiology · 50d
Cleared Jul 11, 1990
MODEL# MPC
K901951
Amerisys
Radiology · 71d
Cleared Feb 05, 1990
U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
K900062
U.S. Imaging, Inc.
Radiology · 33d
Cleared Nov 13, 1989
RADKOR DXG-650R
K895969
Radkor, Inc.
Radiology · 32d
Cleared Sep 12, 1989
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
K894479
Bennett X-Ray Corp.
Radiology · 56d
Cleared Jul 20, 1989
RME 325R
K893674
Fischer Imaging Corp.
Radiology · 66d
Cleared Jul 20, 1989
MAMM-AIRE CP
K893681
Custom Medical Products, Ltd.
Radiology · 65d
Cleared Jun 23, 1989
SENSIMAT
K892657
Transworld X-Ray Corp.
Radiology · 71d
Cleared May 22, 1989
MULTI PULSE POWER UNIT GENERATOR
K892943
GE Medical Systems
Radiology · 31d
Cleared Mar 31, 1989
GX-2000 STATIONARY X-RAY GENERATOR
K890083
Gendex Corp.
Radiology · 80d
Cleared Mar 28, 1989
STAR 36
K890066
Transworld X-Ray Corp.
Radiology · 78d
Cleared Jan 17, 1989
ESP 3-PHASE X-RAY GENERATORS
K884678
Elscint, Inc.
Radiology · 70d