OXO · Class II · 21 CFR 892.1650

FDA Product Code OXO: Image-intensified Fluoroscopic X-ray System, Mobile

Fluoroscopy Of The Human Body.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Beijing East Whale Imaging Technology Co., Ltd. and Ge Oec Medical Systems, Inc..

82
Total
82
Cleared
93d
Avg days
1976
Since
82 devices
73–82 of 82
Cleared Feb 20, 1991
PHILIPS BV-29 IMAGING SYSTEM
K910115
Philips Medical Systems, Inc.
Radiology · 41d
Cleared May 09, 1990
MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
K900193
Imt America, Inc.
Radiology · 113d
Cleared May 09, 1990
MODIFIED ALPHA MC-9R C-ARM
K900967
Instrumentarium Imaging, Inc.
Radiology · 68d
Cleared May 07, 1990
MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K900194
Imt America, Inc.
Radiology · 111d
Cleared Feb 23, 1990
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387
Toshiba America Medical Systems, In.C
Radiology · 109d
Cleared Jul 20, 1989
1 VIDEO TAPE RECORDER MODEL BK-224 H
K892934
Perkins Mfg. Co.
Radiology · 90d
Cleared Jul 14, 1989
MOBILE C-ARM
K893617
Acoma Medical Imaging, Inc.
Radiology · 65d
Cleared Mar 09, 1988
MOBILE C-ARM OMNI 325
K880518
Fischer Imaging Corp.
Radiology · 29d
Cleared May 18, 1982
LIXISCOPE - OR LIXI
K820658
Lixi, Inc.
Radiology · 69d
Cleared Aug 23, 1976
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
K760429
Varian Assoc., Inc.
Radiology · 10d