Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation 892.1650
4510(k)s in 12 months (82 all time)
1recalls in 12 months (50 all time)
46recalls that name a 510(k)
Top companies in OXO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2026 | K253296 | Digital C-ARM with 3D Allengers Medical Systems Limited, IN | OXO |
| Jan 14, 2026 | K252579 | Orthoscan TAU MVP Mini C-Arm System Ziehm-Orthoscan, Inc. | OXO |
| Nov 26, 2025 | K253269 | OEC One CFD Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Nov 6, 2025 | K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) Hefei Chimed Intelligent Machine Co., Ltd., CN | OXO |
| Jul 2, 2025 | K250587 | Orthoscan TAU Mini C-Arm Ziehm-Orthoscan, Inc. | OXO |
| Jan 14, 2025 | K243452 | Orthoscan VERSA Mini C-Arm Ziehm-Orthoscan, Inc. | OXO |
| Dec 27, 2024 | K240828 | OEC One ASD Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Mar 28, 2024 | K233669 | OEC 3D Ge Oec Medical Systems, Inc. | OXO |
| Oct 21, 2021 | K213113 | Orthoscan Tau Mini C-Arm Orthoscan, Inc. | OXO |
| Mar 5, 2021 | K203346 | OEC 3D Ge Oec Medical Systems, Inc. | OXO |
| Nov 8, 2019 | K192819 | OEC Elite Ge Oec Medical Systems, Inc. | OXO |
| Sep 27, 2019 | K190024 | Smart-C Turner Imaging Systems, Inc. | OXO |
| Jun 21, 2019 | K183220 | OrthoScan TAU Mini C-Arm Orthoscan, Inc. | OXO |
| Nov 16, 2018 | K182626 | OEC One Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Nov 24, 2017 | K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant Skanray Technologies Private Limited, IN | OXO |
| Nov 16, 2017 | K172550 | OEC Elite Ge Oec Medical Systems, Inc. | OXO |
| Jul 12, 2017 | K171800 | OEC Elite MiniView Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Jan 4, 2017 | K163429 | B6 Beijing East Whale Imaging Technology Co., Ltd., CN | OXO |
| Jul 20, 2016 | K160984 | MultiScan G-Arm System Beijing East Whale Imaging Technology Co., Ltd., CN | OXO |
| Jun 21, 2016 | K160131 | OEC Elite MiniView Ge Hangwei Medical Systems Co., Ltd., CN | OXO |
| May 20, 2016 | K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System Gemss Medical Systems Co., Ltd., KR | OXO |
| Sep 30, 2015 | K151280 | MultiScan G-Arm System Beijing East Whale Imaging Technology Co., Ltd., CN | OXO |
| Jul 31, 2014 | K141672 | DIGIARC 100AU+ Beijing East Whale Imaging Technology Co., Ltd., CN | OXO |
| Mar 28, 2014 | K133174 | ORTHOSCAN FD MINI C-ARM Orthoscan, Inc. | OXO |
| Nov 7, 2013 | K131423 | G-ARM MULTISCAN SYSTEM Beijing East Whale Imaging Technology Co., Ltd., CN | OXO |
| May 17, 2013 | K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME Ge Healthcare Surgery GE Oec Medical Systems, Inc. | OXO |
| Jul 26, 2012 | K121303 | MOBILE C-ARM Canon Inc. -Medical Equipment Group | OXO |
| Apr 6, 2012 | K120613 | OEC 9900 ELITE Ge Healthcare Surgery GE Oec Medical Systems, Inc. | OXO |
| Apr 6, 2012 | K120388 | INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM Hologic, Inc. | OXO |
| Jan 5, 2012 | K113708 | ORTHOSCAN MOBILE DI MINI C-ARM Orthoscan, Inc. | OXO |
| Jun 17, 2010 | K092564 | O-ARM IMAGING SYSTEM Medtronic Navigation, Inc. (Littleton) | OXO |
| Aug 18, 2006 | K061873 | VERT-X Direx Systems Corp. | OXO |
| Mar 29, 2006 | K060344 | O-ARM IMAGING SYSTEM Breakaway Imaging, LLC | OXO |
| Aug 9, 2005 | K051754 | ORTHOSCAN, ORTHOSCAN HD Orthoscan, Inc. | OXO |
| Jul 7, 2005 | K051490 | GE OEC EVERVIEW 7500 Ge Oec Medical Systems, Inc. | OXO |
| Jun 1, 2005 | K051133 | ARCADIS AVANTIC Siemens Medical Solutions USA, Inc. | OXO |
| May 5, 2005 | K050996 | O-ARM IMAGING SYSTEM Breakaway Imaging, LLC | OXO |
| Feb 17, 2005 | K043379 | SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 Shimadzu Corp. | OXO |
| Jul 22, 2004 | K041213 | 3DSCOPE Direx Systems Corp. | OXO |
| Mar 9, 2004 | K040347 | SIREMOBIL ISO-C 3D Siemens Medical Systems, Inc. | OXO |
| Feb 12, 2004 | K040066 | SIREMOBILE C06 Siemens Medical Solutions USA, Inc. | OXO |
| Nov 12, 2003 | K033066 | XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM Xitec Holdings, LLC | OXO |
| Mar 26, 2002 | K013426 | MOONRAY MOBILE C-ARM Simad S.R.L. | OXO |
| Apr 2, 2001 | K010762 | PHILIPS BV LIBRA Philips Medical Systems, Inc., NL | OXO |
| Mar 12, 2001 | K010393 | APOLLO MOBILE C ARM SYSTEM Cares Built, Inc. | OXO |
| Mar 12, 2001 | K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems | OXO |
| Dec 27, 2000 | K003568 | XISCAN 6000 IMAGING SYSTEM Xitec, Inc. | OXO |
| Dec 1, 2000 | K003266 | SIREMOBIL ISO-C 3D Siemens Medical Solutions USA, Inc. | OXO |
| Apr 14, 2000 | K993092 | SONADA ULTRASOUND SYSTEM Sonovision Corp. | OXO |
| Aug 19, 1999 | K992506 | MINI 6800 DIGITAL MOBILE C-ARM Ge Dec Medical Systems | OXO |
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