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., Ge Oec Medical Systems, Inc. and Orthoscan, Inc..

82
Total
82
Cleared
93d
Avg days
1976
Since
82 devices
49–72 of 82
Cleared Nov 10, 1997
SIREMOBIL CO2
K973598
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jan 17, 1997
DIGISCOPE RX-2 (9 OPTION)
K965013
Medirex, Inc.
Radiology · 32d
Cleared Sep 03, 1996
SIREMOBIL COMPACT
K963093
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared May 20, 1996
ORCA
K960907
Lunar Corp.
Radiology · 76d
Cleared Apr 12, 1996
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
K955251
Imaging Services, Inc.
Radiology · 149d
Cleared Mar 12, 1996
DIGISCOPE RX-2
K960198
Medirex, Inc.
Radiology · 56d
Cleared Oct 18, 1995
PHILIPS BV 300 SERIES
K953910
Philips Medical Systems North America, Inc.
Radiology · 58d
Cleared Mar 16, 1994
SHIMADZU MOBILE X-RAY SYSTEMS
K940294
Shimadzu Precision Instruments, Inc.
Radiology · 54d
Cleared Aug 23, 1993
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447
GE Medical Systems
Radiology · 41d
Cleared Oct 15, 1992
COMET C-125
K914748
Fischer Imaging Corp.
Radiology · 359d
Cleared May 18, 1992
PHILIPS BV26 MOBILE C-ARM STAND
K921255
Philips Medical Systems, Inc.
Radiology · 63d
Cleared Oct 23, 1991
MOBILE X-RAY SYSTEM
K913525
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Feb 20, 1991
PHILIPS BV-29 IMAGING SYSTEM
K910115
Philips Medical Systems, Inc.
Radiology · 41d
Cleared May 09, 1990
MODIFIED ALPHA MC-9R C-ARM
K900967
Instrumentarium Imaging, Inc.
Radiology · 68d
Cleared Feb 23, 1990
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387
Toshiba America Medical Systems, In.C
Radiology · 109d
Cleared Mar 09, 1988
MOBILE C-ARM OMNI 325
K880518
Fischer Imaging Corp.
Radiology · 29d
Cleared Aug 23, 1976
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
K760429
Varian Assoc., Inc.
Radiology · 10d