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 Aug 15, 1988
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF
K880525
Fischer Imaging Corp.
Radiology · 188d
Cleared May 04, 1988
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
K880519
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
K880521
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80
K880522
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75
K880523
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100
K880524
Fischer Imaging Corp.
Radiology · 85d
Cleared Mar 28, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350
K880532
Fischer Imaging Corp.
Radiology · 48d
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 17, 1986
FISCHER IMAGING FX325R X-RAY GENERATOR
K860736
Fischer Imaging Corp.
Radiology · 49d
Cleared Apr 10, 1985
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823
Philips Medical Systems (Cleveland), Inc.
Radiology · 41d
Cleared Aug 17, 1984
SPX GENERATOR
K842348
General Electric Co.
Radiology · 63d
Cleared Feb 24, 1982
SIEMENS POLYDOROS 800
K820112
Siemens Corp.
Radiology · 40d
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
VECTOR-100 X-RAY GENERATOR
K802996
Philips Medical Systems (Cleveland), Inc.
Radiology · 45d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80
K802548
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX 100
K802549
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX 125
K802550
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX100/125
K802551
General Electric Co.
Radiology · 48d
Cleared Jul 28, 1980
CINESCOPE III
K801408
Philips Medical Systems (Cleveland), Inc.
Radiology · 42d
Cleared Dec 20, 1979
POLYPHOS
K792392
Siemens Corp.
Radiology · 24d
Cleared Dec 20, 1979
GIGANTOS 1012 MP
K792393
Siemens Corp.
Radiology · 24d
Cleared Jul 30, 1979
TRIDOROS 712
K791214
Siemens Corp.
Radiology · 28d