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 |