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 Sep 26, 1995
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
K953582
Varian Canada, Inc.
Radiology · 56d
Cleared Sep 08, 1995
N 800 HF
K953831
Nucletron-Oldelft Corp.
Radiology · 24d
Cleared Jul 12, 1995
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
K952822
Shimadzu Corp.
Radiology · 22d
Cleared Jul 06, 1995
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
K952265
Control-X, Inc.
Radiology · 52d
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 Mar 21, 1995
SII 525 APR
K950040
Scott Imaging Intl., Inc.
Radiology · 75d
Cleared Mar 21, 1995
SII 360 APR
K950041
Scott Imaging Intl., Inc.
Radiology · 75d
Cleared Feb 15, 1995
HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS
K945731
Bennett X-Ray Corp.
Radiology · 85d
Cleared Feb 15, 1995
N 800 HF
K950037
Oldelft Corp. of America
Radiology · 42d
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

About Product Code IZO - Regulatory Context