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
97–120 of 163
Cleared Dec 13, 1988
CFX 625
K883976
Fischer Imaging Corp.
Radiology · 84d
Cleared Oct 21, 1988
MICRO-X 100CP
K884134
Fischer Imaging Corp.
Radiology · 21d
Cleared Sep 12, 1988
RAYMAX 2100 MODELS 2130 & 2136
K883431
Raymax Medical Corp.
Radiology · 28d
Cleared Sep 06, 1988
SELDIX 325 TWO PULSE GENERATOR/CONTROL
K883154
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 02, 1988
RADKOR XG-325
K881696
Radkor, Inc.
Radiology · 136d
Cleared Sep 02, 1988
RADKOR, XG-515
K883081
Radkor, Inc.
Radiology · 43d
Cleared Aug 15, 1988
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF
K880525
Fischer Imaging Corp.
Radiology · 188d
Cleared Aug 04, 1988
MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L
K881886
U.S. Imaging, Inc.
Radiology · 91d
Cleared Jul 08, 1988
X-RAY GENERATING SYSTEM TF 1000
K881386
General Medical Merate S.P.A
Radiology · 98d
Cleared Jul 08, 1988
X-RAY GENERATING SYSTEM, TF 800
K881387
Absolute X-Ray Corp.
Radiology · 98d
Cleared Jul 01, 1988
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K
K881795
Shimadzu Precision Instruments, Inc.
Radiology · 65d
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 Mar 03, 1988
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60
K874946
Shimadzu Precision Instruments, Inc.
Radiology · 92d
Cleared Feb 29, 1988
EDEC 60R
K880050
Electromed Intl., Ltd.
Radiology · 54d
Cleared Feb 01, 1988
EDEC 60 R/F
K875341
Electromed Intl., Ltd.
Radiology · 33d
Cleared Jan 29, 1988
EDEC 90C
K875342
Electromed Intl., Ltd.
Radiology · 30d
Cleared Oct 26, 1987
MPG-50 X-RAY GENERATOR
K873544
Thomson-Cgr Medical Corp.
Radiology · 55d
Cleared Aug 12, 1987
POWER-AID INDEPENDENT X-RAY POWER SOURCE
K872445
Advanced Instrument Development, Inc.
Radiology · 50d
Cleared Aug 10, 1987
PROBE, UPTAKE, NUCLEAR
K864624
Carolina Medical Electronics
Radiology · 258d