IZO · Class I · 21 CFR 892.1700

FDA Product Code IZO: Generator, High-voltage, X-ray, Diagnostic

Leading manufacturers include General Electric Co. and Siemens Medical Solutions USA, Inc..

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 Apr 03, 1995
POLYDOROS SX 65 AND 80
K950883
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Apr 28, 1994
SCPU X-RAY GENERATOR
K940227
General Electric Co.
Radiology · 100d
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 Jan 26, 1993
POLYDOROS C
K924078
Siemens Medical Solutions USA, Inc.
Radiology · 167d
Cleared Dec 17, 1992
POLYDOROS XS50 AND SX80
K923786
Siemens Medical Solutions USA, Inc.
Radiology · 142d
Cleared Jul 21, 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K921951
General Electric Co.
Radiology · 85d
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 Aug 17, 1984
SPX GENERATOR
K842348
General Electric Co.
Radiology · 63d
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 Jan 18, 1977
MPX 80
K770006
General Electric Co.
Radiology · 15d
Cleared Jan 18, 1977
MPX 100
K770007
General Electric Co.
Radiology · 15d
Cleared Jan 18, 1977
MPX 125
K770008
General Electric Co.
Radiology · 15d

About Product Code IZO - Regulatory Context