OXO
82 FDA 510(k) clearances · Product code
68 daysmedian time to decision
211 days90th percentile
82clearances measured
FDA profile
- Official device name
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1650
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- FDA definition
- Fluoroscopy of the human body.
- Adverse events (MAUDE)
- 2021: 554 · 2022: 295 · 2023: 275 · 2024: 192 · 2025: 124 · 2026: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Digital C-ARM with 3D (K253296) | Allengers Medical Systems Limited | 2026-06-05 |
| Orthoscan TAU MVP Mini C-Arm System (K252579) | Ziehm-Orthoscan, Inc. | 2026-01-14 |
| OEC One CFD (K253269) | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 |
| Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (K251004) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 |
| Orthoscan TAU Mini C-Arm (K250587) | Ziehm-Orthoscan, Inc. | 2025-07-02 |
| Orthoscan VERSA Mini C-Arm (K243452) | Ziehm-Orthoscan, Inc. | 2025-01-14 |
| OEC One ASD (K240828) | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 |
| OEC 3D (K233669) | Ge Oec Medical Systems, Inc. | 2024-03-28 |
| Orthoscan Tau Mini C-Arm (K213113) | Orthoscan, Inc. | 2021-10-21 |
| OEC 3D (K203346) | Ge Oec Medical Systems, Inc. | 2021-03-05 |
| OEC Elite (K192819) | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| Smart-C (K190024) | Turner Imaging Systems, Inc. | 2019-09-27 |
| OrthoScan TAU Mini C-Arm (K183220) | Orthoscan, Inc. | 2019-06-21 |
| OEC One (K182626) | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 |
| Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant (K170946) | Skanray Technologies Private Limited | 2017-11-24 |
| OEC Elite (K172550) | Ge Oec Medical Systems, Inc. | 2017-11-16 |
| OEC Elite MiniView (K171800) | Ge Hualun Medical Systems Co. , Ltd. | 2017-07-12 |
| B6 (K163429) | Beijing East Whale Imaging Technology Co., Ltd. | 2017-01-04 |
| MultiScan G-Arm System (K160984) | Beijing East Whale Imaging Technology Co., Ltd. | 2016-07-20 |
| OEC Elite MiniView (K160131) | Ge Hangwei Medical Systems Co., Ltd. | 2016-06-21 |
| GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System (K160065) | Gemss Medical Systems Co., Ltd. | 2016-05-20 |
| MultiScan G-Arm System (K151280) | Beijing East Whale Imaging Technology Co., Ltd. | 2015-09-30 |
| DIGIARC 100AU+ (K141672) | Beijing East Whale Imaging Technology Co., Ltd. | 2014-07-31 |
| ORTHOSCAN FD MINI C-ARM (K133174) | Orthoscan, Inc. | 2014-03-28 |
| G-ARM MULTISCAN SYSTEM (K131423) | Beijing East Whale Imaging Technology Co., Ltd. | 2013-11-07 |
| OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME (K123603) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013-05-17 |
| MOBILE C-ARM (K121303) | Canon Inc. -Medical Equipment Group | 2012-07-26 |
| INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM (K120388) | Hologic, Inc. | 2012-04-06 |
| OEC 9900 ELITE (K120613) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 |
| ORTHOSCAN MOBILE DI MINI C-ARM (K113708) | Orthoscan, Inc. | 2012-01-05 |
| O-ARM IMAGING SYSTEM (K092564) | Medtronic Navigation, Inc. (Littleton) | 2010-06-17 |
| VERT-X (K061873) | Direx Systems Corp. | 2006-08-18 |
| O-ARM IMAGING SYSTEM (K060344) | Breakaway Imaging, LLC | 2006-03-29 |
| ORTHOSCAN, ORTHOSCAN HD (K051754) | Orthoscan, Inc. | 2005-08-09 |
| GE OEC EVERVIEW 7500 (K051490) | Ge Oec Medical Systems, Inc. | 2005-07-07 |
| ARCADIS AVANTIC (K051133) | Siemens Medical Solutions USA, Inc. | 2005-06-01 |
| O-ARM IMAGING SYSTEM (K050996) | Breakaway Imaging, LLC | 2005-05-05 |
| SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 (K043379) | Shimadzu Corp. | 2005-02-17 |
| 3DSCOPE (K041213) | Direx Systems Corp. | 2004-07-22 |
| SIREMOBIL ISO-C 3D (K040347) | Siemens Medical Systems, Inc. | 2004-03-09 |
| SIREMOBILE C06 (K040066) | Siemens Medical Solutions USA, Inc. | 2004-02-12 |
| XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM (K033066) | Xitec Holdings, LLC | 2003-11-12 |
| MOONRAY MOBILE C-ARM (K013426) | Simad S.R.L. | 2002-03-26 |
| PHILIPS BV LIBRA (K010762) | Philips Medical Systems, Inc. | 2001-04-02 |
| FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM (K003837) | Ge Oec Medical Systems | 2001-03-12 |
| APOLLO MOBILE C ARM SYSTEM (K010393) | Cares Built, Inc. | 2001-03-12 |
| XISCAN 6000 IMAGING SYSTEM (K003568) | Xitec, Inc. | 2000-12-27 |
| SIREMOBIL ISO-C 3D (K003266) | Siemens Medical Solutions USA, Inc. | 2000-12-01 |
| SONADA ULTRASOUND SYSTEM (K993092) | Sonovision Corp. | 2000-04-14 |
| MINI 6800 DIGITAL MOBILE C-ARM (K992506) | Ge Dec Medical Systems | 1999-08-19 |
| XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM (K984406) | Xitec, Inc. | 1999-02-02 |
| PHILIPS BV300 SERIES RELEASE 2.1 (K982706) | Philips Medical Systems, Inc. | 1998-09-02 |
| PATHFINDER MOBILE C ARM (K981131) | Acoma Medical Imaging, Inc. | 1998-06-26 |
| ACCENT 16, ACCENT 22 (K980322) | GE Medical Systems | 1998-04-24 |
| SIREMOBIL CO2 (K973598) | Siemens Medical Solutions USA, Inc. | 1997-11-10 |
| DIGISCOPE RX-2 (9 OPTION) (K965013) | Medirex, Inc. | 1997-01-17 |
| SIREMOBIL COMPACT (K963093) | Siemens Medical Solutions USA, Inc. | 1996-09-03 |
| ORCA (K960907) | Lunar Corp. | 1996-05-20 |
| OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM (K955251) | Imaging Services, Inc. | 1996-04-12 |
| DIGISCOPE RX-2 (K960198) | Medirex, Inc. | 1996-03-12 |
| PHILIPS BV 300 SERIES (K953910) | Philips Medical Systems North America, Inc. | 1995-10-18 |
| SERIES 6600 DIGITAL MOBILE C-ARM (K951765) | Ge Dec Medical Systems | 1995-05-11 |
| SHIMADZU MOBILE X-RAY SYSTEMS (K940294) | Shimadzu Precision Instruments, Inc. | 1994-03-16 |
| MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY (K934700) | Tempo Technology, Inc. | 1994-03-16 |
| PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER (K935580) | Precise Optics | 1994-03-16 |
| ORTHOTRAC COAXIAL LASER (K933431) | Trac Medical, Inc. | 1993-10-05 |
| STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM (K933447) | GE Medical Systems | 1993-08-23 |
| 9600 FLUOROSCOPIC IMAGING SYSTEM (K926056) | Oec-Diasonics, Inc. | 1993-01-21 |
| COMET C-125 (K914748) | Fischer Imaging Corp. | 1992-10-15 |
| PHILIPS BV26 MOBILE C-ARM STAND (K921255) | Philips Medical Systems, Inc. | 1992-05-18 |
| SWEMAC REISON BIPLANAR 300 (K911739) | Seemac Reison AB Co. | 1991-10-23 |
| MOBILE X-RAY SYSTEM (K913525) | Siemens Medical Solutions USA, Inc. | 1991-10-23 |
| PHILIPS BV-29 IMAGING SYSTEM (K910115) | Philips Medical Systems, Inc. | 1991-02-20 |
| MODIFIED ALPHA MC-9R C-ARM (K900967) | Instrumentarium Imaging, Inc. | 1990-05-09 |
| MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT (K900193) | Imt America, Inc. | 1990-05-09 |
| MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT (K900194) | Imt America, Inc. | 1990-05-07 |
| SXT-60F/60M MOBILE C ARM X-RAY UNIT (K896387) | Toshiba America Medical Systems, In.C | 1990-02-23 |
| 1 VIDEO TAPE RECORDER MODEL BK-224 H (K892934) | Perkins Mfg. Co. | 1989-07-20 |
| MOBILE C-ARM (K893617) | Acoma Medical Imaging, Inc. | 1989-07-14 |
| MOBILE C-ARM OMNI 325 (K880518) | Fischer Imaging Corp. | 1988-03-09 |
| LIXISCOPE - OR LIXI (K820658) | Lixi, Inc. | 1982-05-18 |
| FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS. (K760429) | Varian Assoc., Inc. | 1976-08-23 |
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