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
25–48 of 82
Cleared Nov 07, 2013
G-ARM MULTISCAN SYSTEM
K131423
Beijing East Whale Imaging Technology Co., Ltd.
Radiology · 175d
Cleared May 17, 2013
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
K123603
Ge Healthcare Surgery GE Oec Medical Systems, Inc.
Radiology · 177d
Cleared Jul 26, 2012
MOBILE C-ARM
K121303
Canon Inc. -Medical Equipment Group
Radiology · 86d
Cleared Apr 06, 2012
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388
Hologic, Inc.
Radiology · 59d
Cleared Apr 06, 2012
OEC 9900 ELITE
K120613
Ge Healthcare Surgery GE Oec Medical Systems, Inc.
Radiology · 37d
Cleared Jan 05, 2012
ORTHOSCAN MOBILE DI MINI C-ARM
K113708
Orthoscan, Inc.
Radiology · 20d
Cleared Jun 17, 2010
O-ARM IMAGING SYSTEM
K092564
Medtronic Navigation, Inc. (Littleton)
Radiology · 301d
Cleared Aug 18, 2006
VERT-X
K061873
Direx Systems Corp.
Radiology · 46d
Cleared Mar 29, 2006
O-ARM IMAGING SYSTEM
K060344
Breakaway Imaging, LLC
Radiology · 47d
Cleared Aug 09, 2005
ORTHOSCAN, ORTHOSCAN HD
K051754
Orthoscan, Inc.
Radiology · 41d
Cleared Jul 07, 2005
GE OEC EVERVIEW 7500
K051490
Ge Oec Medical Systems, Inc.
Radiology · 31d
Cleared Jun 01, 2005
ARCADIS AVANTIC
K051133
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared May 05, 2005
O-ARM IMAGING SYSTEM
K050996
Breakaway Imaging, LLC
Radiology · 15d
Cleared Feb 17, 2005
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
K043379
Shimadzu Corp.
Radiology · 71d
Cleared Jul 22, 2004
3DSCOPE
K041213
Direx Systems Corp.
Radiology · 73d
Cleared Mar 09, 2004
SIREMOBIL ISO-C 3D
K040347
Siemens Medical Systems, Inc.
Radiology · 26d
Cleared Feb 12, 2004
SIREMOBILE C06
K040066
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Nov 12, 2003
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
K033066
Xitec Holdings, LLC
Radiology · 44d
Cleared Mar 26, 2002
MOONRAY MOBILE C-ARM
K013426
Simad S.R.L.
Radiology · 161d
Cleared Apr 02, 2001
PHILIPS BV LIBRA
K010762
Philips Medical Systems, Inc.
Radiology · 19d
Cleared Mar 12, 2001
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
K003837
Ge Oec Medical Systems
Radiology · 90d
Cleared Mar 12, 2001
APOLLO MOBILE C ARM SYSTEM
K010393
Cares Built, Inc.
Radiology · 32d
Cleared Dec 27, 2000
XISCAN 6000 IMAGING SYSTEM
K003568
Xitec, Inc.
Radiology · 37d
Cleared Dec 01, 2000
SIREMOBIL ISO-C 3D
K003266
Siemens Medical Solutions USA, Inc.
Radiology · 44d