IZJ · Class II · 21 CFR 892.1620

FDA Product Code IZJ: Camera, X-ray, Fluorographic, Cine Or Spot

Leading manufacturers include Siemens Corp., Philips Medical Systems (Cleveland), Inc. and Fairmontmedical.

12
Total
12
Cleared
63d
Avg days
1979
Since

FDA 510(k) Cleared Camera, X-ray, Fluorographic, Cine Or Spot Devices (Product Code IZJ)

12 devices
1–12 of 12
Cleared Oct 09, 1997
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
K972130
Fairmontmedical
Radiology · 125d
Cleared Jan 30, 1995
DSP OPTION
K945580
Philips Medical Systems (Cleveland), Inc.
Radiology · 77d
Cleared Jul 17, 1992
PHILIPS DSI SYSTEM RELEASE 3.2
K920793
Philips Medical Systems, Inc.
Radiology · 147d
Cleared May 18, 1988
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
K881688
Adac Laboratories
Radiology · 29d
Cleared Oct 16, 1985
CANON X-RAY 35MM CINE CAMERA CSI-35
K853983
Canon USA, Inc.
Radiology · 19d
Cleared Feb 26, 1981
SIRCAM 103
K810191
Siemens Corp.
Radiology · 34d
Cleared Dec 20, 1979
SIRCAM 106
K792394
Siemens Corp.
Radiology · 24d

About Product Code IZJ - Regulatory Context