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

FDA 510(k) Cleared Generator, High-voltage, X-ray, Diagnostic Devices (Product Code IZO)

163 devices
1–24 of 163
Cleared Nov 24, 1995
MPH50, MPH65, AND MPH80
K954666
GE Medical Systems
Radiology · 45d
Cleared Jul 12, 1995
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
K952822
Shimadzu Corp.
Radiology · 22d
Cleared Apr 03, 1995
POLYDOROS SX 65 AND 80
K950883
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Mar 31, 1995
COMPACT-X
K950694
Electromed Intl., Ltd.
Radiology · 45d
Cleared Mar 23, 1995
DIGITAL 625HF
K950291
Fischer Imaging Corp.
Radiology · 57d
Cleared Mar 21, 1995
UD 150L-F
K945452
Shimadzu Medical Systems
Radiology · 134d
Cleared Mar 21, 1995
UD 150L-R II
K945453
Shimadzu Medical Systems
Radiology · 134d
Cleared Feb 15, 1995
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
K945731
Bennett X-Ray Corp.
Radiology · 85d
Cleared Dec 27, 1994
KXO-80G
K945668
Toshiba America Medical Systems, In.C
Radiology · 40d
Cleared Oct 13, 1994
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
K942731
Shimadzu Corp.
Radiology · 147d
Cleared Sep 16, 1994
MICRO X-50 HF
K944147
Fischer Imaging Corp.
Radiology · 22d
Cleared Sep 16, 1994
MICRO X-30HF
K944148
Fischer Imaging Corp.
Radiology · 22d
Cleared Sep 16, 1994
MICRO X-80 HF
K944149
Fischer Imaging Corp.
Radiology · 22d
Cleared Sep 16, 1994
MICRO X-65 HF
K944150
Fischer Imaging Corp.
Radiology · 22d
Cleared Aug 22, 1994
VASCULAR MP X-RAY GENERATOR
K943652
GE Medical Systems
Radiology · 25d
Cleared Aug 17, 1994
RSX-525HF
K943504
Fischer Imaging Corp.
Radiology · 28d
Cleared Jul 29, 1994
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
K942778
Varian Assoc., Inc.
Radiology · 46d
Cleared Jun 07, 1994
MODEL TM EP HIGH VOLTAGE GENERATOR
K942100
Continental X-Ray Corp.
Radiology · 42d
Cleared May 26, 1994
MOLYBDENUM/RHODIUM FILTERS
K934686
Continental X-Ray Corp.
Radiology · 239d
Cleared Apr 28, 1994
SCPU X-RAY GENERATOR
K940227
General Electric Co.
Radiology · 100d
Cleared Dec 13, 1993
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
K934967
Shimadzu Corp.
Radiology · 59d
Cleared Dec 13, 1993
RADIOGRAPHIC GENERATOR HFQ-WHIS
K935068
Bennett X-Ray Corp.
Radiology · 49d
Cleared Nov 24, 1993
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G
K933471
Shimadzu Corp.
Radiology · 132d
Cleared Oct 07, 1993
PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
K933650
Philips Medical Systems North America, Inc.
Radiology · 72d

About Product Code IZO - Regulatory Context