FDA 510(k) Applications for Medical Device Product Code "OXO"

FDA 510(k) Number Applicant Device Name Decision Date
K981131 ACOMA MEDICAL IMAGING, INC. PATHFINDER MOBILE C ARM 06/26/1998
K160984 BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD MultiScan G-Arm System 07/20/2016
K131423 BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. G-ARM MULTISCAN SYSTEM 11/07/2013
K163429 Beijing East Whale Imaging Technology Co., Ltd B6 01/04/2017
K141672 BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. DIGIARC 100AU+ 07/31/2014
K151280 BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. MultiScan G-Arm System 09/30/2015
K050996 BREAKAWAY IMAGING, LLC O-ARM IMAGING SYSTEM 05/05/2005
K060344 BREAKAWAY IMAGING, LLC O-ARM IMAGING SYSTEM 03/29/2006
K121303 CANON, INC.-MEDICAL EQUIPMENT GROUP MOBILE C-ARM 07/26/2012
K010393 CARES BUILT, INC. APOLLO MOBILE C ARM SYSTEM 03/12/2001
K041213 DIREX SYSTEMS CORP. 3DSCOPE 07/22/2004
K061873 DIREX SYSTEMS CORP. VERT-X 08/18/2006
K992506 GE DEC MEDICAL SYSTEMS MINI 6800 DIGITAL MOBILE C-ARM 08/19/1999
K160131 GE HANGWEI MEDICAL SYSTEMS CO., LTD. OEC Elite MiniView 06/21/2016
K120613 GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC OEC 9900 ELITE 04/06/2012
K123603 GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME 05/17/2013
K182626 GE Hualun Medical Systems Co., Ltd. OEC One 11/16/2018
K171800 GE Hualun Medical Systems Co.Ltd. OEC Elite MiniView 07/12/2017
K980322 GE MEDICAL SYSTEMS ACCENT 16, ACCENT 22 04/24/1998
K003837 GE OEC MEDICAL SYSTEMS FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM 03/12/2001
K051490 GE OEC MEDICAL SYSTEMS, INC. GE OEC EVERVIEW 7500 07/07/2005
K203346 GE OEC Medical Systems, Inc. OEC 3D 03/05/2021
K192819 GE OEC Medical Systems, Inc. OEC Elite 11/08/2019
K172550 GE OEC Medical Systems, Inc. OEC Elite 11/16/2017
K160065 GEMSS MEDICAL SYSTEMS CO., LTD GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System 05/20/2016
K120388 HOLOGIC, INC. INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM 04/06/2012
K955251 IMAGING SERVICES, INC. OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM 04/12/1996
K960907 LUNAR CORP. ORCA 05/20/1996
K960198 MEDIREX, INC. DIGISCOPE RX-2 03/12/1996
K965013 MEDIREX, INC. DIGISCOPE RX-2 (9 OPTION) 01/17/1997
K092564 MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM IMAGING SYSTEM 06/17/2010
K133174 ORTHOSCAN, INC. ORTHOSCAN FD MINI C-ARM 03/28/2014
K113708 ORTHOSCAN, INC. ORTHOSCAN MOBILE DI MINI C-ARM 01/05/2012
K183220 Orthoscan, Inc. OrthoScan TAU Mini C-Arm 06/21/2019
K213113 Orthoscan, Inc. Orthoscan Tau Mini C-Arm 10/21/2021
K051754 ORTHOSCAN, INC. ORTHOSCAN, ORTHOSCAN HD 08/09/2005
K010762 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS BV LIBRA 04/02/2001
K982706 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS BV300 SERIES RELEASE 2.1 09/02/1998
K043379 SHIMADZU CORP. SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 02/17/2005
K051133 SIEMENS MEDICAL SOLUTIONS USA, INC. ARCADIS AVANTIC 06/01/2005
K973598 SIEMENS MEDICAL SOLUTIONS USA, INC. SIREMOBIL CO2 11/10/1997
K963093 SIEMENS MEDICAL SOLUTIONS USA, INC. SIREMOBIL COMPACT 09/03/1996
K003266 SIEMENS MEDICAL SOLUTIONS USA, INC. SIREMOBIL ISO-C 3D 12/01/2000
K040066 SIEMENS MEDICAL SOLUTIONS USA, INC. SIREMOBILE C06 02/12/2004
K040347 SIEMENS MEDICAL SYSTEMS, INC. SIREMOBIL ISO-C 3D 03/09/2004
K013426 SIMAD S.R.L. MOONRAY MOBILE C-ARM 03/26/2002
K170946 Skanray Technologies Private Limited Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant 11/24/2017
K993092 SONOVISION CORP. SONADA ULTRASOUND SYSTEM 04/14/2000
K190024 Turner Imaging Systems, Inc. Smart-C 09/27/2019
K033066 XITEC HOLDINGS LLC. XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM 11/12/2003
K003568 XITEC, INC. XISCAN 6000 IMAGING SYSTEM 12/27/2000
K984406 XITEC, INC. XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM 02/02/1999


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