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
49–72 of 163
Cleared May 28, 1992
P2900 X-RAY GENERATOR
K921516
Precise Optics Photo Medic Equipment, Inc.
Radiology · 58d
Cleared Apr 27, 1992
X-RAY HIGH VOLTAGE GENERATOR ED 125L
K920730
Shimadzu Medical Systems
Radiology · 69d
Cleared Jan 09, 1992
GEN-X 800/500
K915227
Swiss Ray Medical Systems
Radiology · 50d
Cleared Jan 09, 1992
GEN-X 800/300
K915339
Swissray Finatech, Inc.
Radiology · 50d
Cleared Dec 20, 1991
OPTIMA
K913222
Olympic Controls Corp.
Radiology · 154d
Cleared Nov 27, 1991
MICRO-X 50 HF
K914236
Fischer Imaging Corp.
Radiology · 68d
Cleared Nov 27, 1991
MICRO-X 30 HF
K914266
Fischer Imaging Corp.
Radiology · 65d
Cleared Nov 05, 1991
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
K913577
Control-X, Inc.
Radiology · 85d
Cleared Nov 01, 1991
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
K913578
Control-X, Inc.
Radiology · 81d
Cleared Oct 30, 1991
GEN-X 800/800
K914301
Swissray Finatech, Inc.
Radiology · 35d
Cleared Oct 30, 1991
GEN-X 800/650
K914302
Swissray Finatech, Inc.
Radiology · 35d
Cleared Oct 24, 1991
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
K911562
Continental X-Ray Corp.
Radiology · 199d
Cleared Sep 23, 1991
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
K913234
Varian Canada, Inc.
Radiology · 63d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10
K913062
Shimadzu Medical Systems
Radiology · 68d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10
K913063
Shimadzu Medical Systems
Radiology · 68d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L
K913064
Shimadzu Medical Systems
Radiology · 68d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L
K913065
Shimadzu Medical Systems
Radiology · 68d
Cleared Aug 28, 1991
MICRO-X 15 HF
K912449
Fischer Imaging Corp.
Radiology · 86d
Cleared Jun 17, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
K911280
Shimadzu Medical Systems
Radiology · 84d
Cleared Jun 06, 1991
SELECTOR MD (50KW AND 80 KW)
K910650
Hofmann-Nagel Medical Systems, Inc.
Radiology · 112d
Cleared Apr 16, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
K911339
Shimadzu Medical Systems
Radiology · 21d
Cleared Apr 08, 1991
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
K910020
Capintec Instruments, Inc.
Radiology · 95d
Cleared Mar 07, 1991
VPW 2877E6 X-RAY POWER SUPPLY
K910820
Varian Canada, Inc.
Radiology · 10d
Cleared Mar 06, 1991
MICRO-X 80HF
K905695
Fischer Imaging Corp.
Radiology · 77d