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
121–144 of 163
Cleared Jul 15, 1987
TRANSWORLD 360V, MODEL A1-4040
K872357
Transworld X-Ray Corp.
Radiology · 27d
Cleared Mar 31, 1987
EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR
K871145
Electromed Intl., Ltd.
Radiology · 8d
Cleared Mar 20, 1987
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
K870851
Electromed Intl., Ltd.
Radiology · 17d
Cleared Dec 15, 1986
PORTA RAY MODEL 325
K864339
Porta Ray, Inc.
Radiology · 41d
Cleared Aug 14, 1986
SMX GENERATOR
K862800
General Electric Co.
Radiology · 23d
Cleared Jul 29, 1986
MVP GENERATOR, CATALOG NO. H8018
K862682
General Electric Co.
Radiology · 14d
Cleared Apr 22, 1986
GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR
K854499
Gendex Corp.
Radiology · 161d
Cleared Apr 17, 1986
FISCHER IMAGING FX325R X-RAY GENERATOR
K860736
Fischer Imaging Corp.
Radiology · 49d
Cleared Jan 30, 1986
TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR
K860203
Tingle X-Ray Products, Inc.
Radiology · 8d
Cleared Nov 29, 1985
EDEC 2000
K852908
Electromed Intl., Ltd.
Radiology · 143d
Cleared Apr 10, 1985
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823
Philips Medical Systems (Cleveland), Inc.
Radiology · 41d
Cleared Apr 10, 1985
HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR
K851011
Hofmann X-Ray of America, Inc.
Radiology · 29d
Cleared Apr 09, 1985
XMA 325 (X-RAY GENERATOR)
K850117
Summit Industries, Inc.
Radiology · 85d
Cleared Mar 01, 1985
EDEC-100
K843443
Electromed Intl., Ltd.
Radiology · 178d
Cleared Aug 17, 1984
SPX GENERATOR
K842348
General Electric Co.
Radiology · 63d
Cleared Dec 16, 1983
PROCESS 100 ST
K833846
Cgr Medical Corp.
Radiology · 92d
Cleared Mar 19, 1982
ESP SERIES (X-RAY GENERATORS
K820593
Xonics Medical Systems, Inc.
Radiology · 15d
Cleared Mar 05, 1982
TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
K820307
Tecnomed, Inc.
Radiology · 29d
Cleared Feb 24, 1982
SIEMENS POLYDOROS 800
K820112
Siemens Corp.
Radiology · 40d
Cleared Nov 24, 1981
COMPTAR III
K813051
Cgr Medical Corp.
Radiology · 26d
Cleared Oct 13, 1981
POLYPHOS 500
K812616
Siemens Corp.
Radiology · 28d
Cleared Jun 29, 1981
ECCO GENERATOR
K811198
Philips Medical Systems (Cleveland), Inc.
Radiology · 60d
Cleared Jan 09, 1981
CINESCOPE III RADIOGRAPHIC GENERATOR
K802941
Controtec, Inc.
Radiology · 51d
Cleared Jan 09, 1981
VECTOR-100 X-RAY GENERATOR
K802996
Philips Medical Systems (Cleveland), Inc.
Radiology · 45d