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 Apr 14, 2000
SONADA ULTRASOUND SYSTEM
K993092
Sonovision Corp.
Radiology · 211d
Cleared Aug 19, 1999
MINI 6800 DIGITAL MOBILE C-ARM
K992506
Ge Dec Medical Systems
Radiology · 23d
Cleared Feb 02, 1999
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
K984406
Xitec, Inc.
Radiology · 55d
Cleared Sep 02, 1998
PHILIPS BV300 SERIES RELEASE 2.1
K982706
Philips Medical Systems, Inc.
Radiology · 29d
Cleared Jun 26, 1998
PATHFINDER MOBILE C ARM
K981131
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Apr 24, 1998
ACCENT 16, ACCENT 22
K980322
GE Medical Systems
Radiology · 87d
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 May 11, 1995
SERIES 6600 DIGITAL MOBILE C-ARM
K951765
Ge Dec Medical Systems
Radiology · 24d
Cleared Mar 16, 1994
MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY
K934700
Tempo Technology, Inc.
Radiology · 167d
Cleared Mar 16, 1994
PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
K935580
Precise Optics
Radiology · 118d
Cleared Mar 16, 1994
SHIMADZU MOBILE X-RAY SYSTEMS
K940294
Shimadzu Precision Instruments, Inc.
Radiology · 54d
Cleared Oct 05, 1993
ORTHOTRAC COAXIAL LASER
K933431
Trac Medical, Inc.
Radiology · 83d
Cleared Aug 23, 1993
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447
GE Medical Systems
Radiology · 41d
Cleared Jan 21, 1993
9600 FLUOROSCOPIC IMAGING SYSTEM
K926056
Oec-Diasonics, Inc.
Radiology · 51d
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
SWEMAC REISON BIPLANAR 300
K911739
Seemac Reison AB Co.
Radiology · 189d
Cleared Oct 23, 1991
MOBILE X-RAY SYSTEM
K913525
Siemens Medical Solutions USA, Inc.
Radiology · 76d