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
25–48 of 163
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
CONCEPT ONE
K933777
Innerscan, Inc.
Radiology · 132d
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
Cleared Sep 07, 1993
POYDOROS LX
K931930
Siemens Medical Solutions USA, Inc.
Radiology · 144d
Cleared Sep 07, 1993
POLYDOROS IS
K933240
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Jul 27, 1993
LCR GENERATOR
K931998
Philips Medical Systems (Cleveland), Inc.
Radiology · 95d
Cleared May 19, 1993
RSX 30HF
K930792
Fischer Imaging Corp.
Radiology · 92d
Cleared May 19, 1993
ADVANTX SYSTEM
K931049
GE Medical Systems
Radiology · 79d
Cleared Mar 26, 1993
MAGMA XHF-30, XHF-40, XHF-50
K926365
Imaging and X-Ray Intl., Inc.
Radiology · 94d
Cleared Feb 12, 1993
PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
K920349
Control-X, Inc.
Radiology · 385d
Cleared Feb 12, 1993
PCX 650HF RADIOGRAPHIC X-RAY
K920351
Control-X, Inc.
Radiology · 385d
Cleared Feb 02, 1993
OLYMP-X,X-RAY GENERATOR
K925684
Afp Imaging Corp.
Radiology · 82d
Cleared Jan 26, 1993
POLYDOROS C
K924078
Siemens Medical Solutions USA, Inc.
Radiology · 167d
Cleared Dec 28, 1992
PHILIPS MEDIO CP FAMILY
K925105
Philips Medical Systems, Inc.
Radiology · 81d
Cleared Dec 28, 1992
PHILIPS SUPER CP FAMILY
K925844
Philips Medical Systems, Inc.
Radiology · 40d
Cleared Dec 17, 1992
POLYDOROS XS50 AND SX80
K923786
Siemens Medical Solutions USA, Inc.
Radiology · 142d
Cleared Oct 15, 1992
X-RAY CONTROL AND HI-VOLTAGE GENERATOR
K921875
Continental X-Ray Corp.
Radiology · 178d
Cleared Sep 11, 1992
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT
K922814
Bay Shore Medical Equipment Corp.
Radiology · 101d
Cleared Jul 27, 1992
ATC725, ATC525, AND AP300
K922165
Gendex Corp.
Radiology · 80d
Cleared Jul 21, 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K921951
General Electric Co.
Radiology · 85d