FDA Product Code
FDA Product Code OXO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1650
510(k) Clearances — 82 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | 2026-06-05 | Traditional | PDF ↗ |
| K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026-01-14 | Traditional | PDF ↗ |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 | Traditional | PDF ↗ |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 | Traditional | PDF ↗ |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-07-02 | Special | PDF ↗ |
| K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-01-14 | Traditional | PDF ↗ |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 | Traditional | PDF ↗ |
| K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | 2024-03-28 | Traditional | PDF ↗ |
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021-10-21 | Special | PDF ↗ |
| K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | 2021-03-05 | Traditional | PDF ↗ |
| K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | 2019-11-08 | Special | PDF ↗ |
| K190024 | Smart-C | Turner Imaging Systems, Inc. | 2019-09-27 | Abbreviated | PDF ↗ |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019-06-21 | Traditional | PDF ↗ |
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 | Traditional | PDF ↗ |
| 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 | 2017-11-24 | Traditional | PDF ↗ |
| K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017-11-16 | Traditional | PDF ↗ |
| K171800 | OEC Elite MiniView | Ge Hualun Medical Systems Co. , Ltd. | 2017-07-12 | Special | PDF ↗ |
| K163429 | B6 | Beijing East Whale Imaging Technology Co., Ltd. | 2017-01-04 | Traditional | PDF ↗ |
| K160984 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2016-07-20 | Traditional | PDF ↗ |
| K160131 | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | 2016-06-21 | Traditional | PDF ↗ |
| K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System | Gemss Medical Systems Co., Ltd. | 2016-05-20 | Traditional | PDF ↗ |
| K151280 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2015-09-30 | Special | PDF ↗ |
| K141672 | DIGIARC 100AU+ | Beijing East Whale Imaging Technology Co., Ltd. | 2014-07-31 | Special | PDF ↗ |
| K133174 | ORTHOSCAN FD MINI C-ARM | Orthoscan, Inc. | 2014-03-28 | Traditional | PDF ↗ |
| K131423 | G-ARM MULTISCAN SYSTEM | Beijing East Whale Imaging Technology Co., Ltd. | 2013-11-07 | Traditional | PDF ↗ |
| K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013-05-17 | Traditional | PDF ↗ |
| K121303 | MOBILE C-ARM | Canon Inc. -Medical Equipment Group | 2012-07-26 | Traditional | PDF ↗ |
| K120388 | INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | Hologic, Inc. | 2012-04-06 | Special | PDF ↗ |
| K120613 | OEC 9900 ELITE | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 | Special | PDF ↗ |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | Orthoscan, Inc. | 2012-01-05 | Traditional | PDF ↗ |
| K092564 | O-ARM IMAGING SYSTEM | Medtronic Navigation, Inc. (Littleton) | 2010-06-17 | Abbreviated | PDF ↗ |
| K061873 | VERT-X | Direx Systems Corp. | 2006-08-18 | Traditional | PDF ↗ |
| K060344 | O-ARM IMAGING SYSTEM | Breakaway Imaging, LLC | 2006-03-29 | Traditional | PDF ↗ |
| K051754 | ORTHOSCAN, ORTHOSCAN HD | Orthoscan, Inc. | 2005-08-09 | Traditional | PDF ↗ |
| K051490 | GE OEC EVERVIEW 7500 | Ge Oec Medical Systems, Inc. | 2005-07-07 | Traditional | PDF ↗ |
| K051133 | ARCADIS AVANTIC | Siemens Medical Solutions USA, Inc. | 2005-06-01 | Traditional | PDF ↗ |
| K050996 | O-ARM IMAGING SYSTEM | Breakaway Imaging, LLC | 2005-05-05 | Abbreviated | PDF ↗ |
| K043379 | SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 | Shimadzu Corp. | 2005-02-17 | Abbreviated | PDF ↗ |
| K041213 | 3DSCOPE | Direx Systems Corp. | 2004-07-22 | Special | PDF ↗ |
| K040347 | SIREMOBIL ISO-C 3D | Siemens Medical Systems, Inc. | 2004-03-09 | Traditional | PDF ↗ |
| K040066 | SIREMOBILE C06 | Siemens Medical Solutions USA, Inc. | 2004-02-12 | Special | PDF ↗ |
| K033066 | XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM | Xitec Holdings, LLC | 2003-11-12 | Special | PDF ↗ |
| K013426 | MOONRAY MOBILE C-ARM | Simad S.R.L. | 2002-03-26 | Traditional | PDF ↗ |
| K010762 | PHILIPS BV LIBRA | Philips Medical Systems, Inc. | 2001-04-02 | Traditional | PDF ↗ |
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM | Ge Oec Medical Systems | 2001-03-12 | Traditional | PDF ↗ |
| K010393 | APOLLO MOBILE C ARM SYSTEM | Cares Built, Inc. | 2001-03-12 | Traditional | PDF ↗ |
| K003568 | XISCAN 6000 IMAGING SYSTEM | Xitec, Inc. | 2000-12-27 | Traditional | PDF ↗ |
| K003266 | SIREMOBIL ISO-C 3D | Siemens Medical Solutions USA, Inc. | 2000-12-01 | Traditional | PDF ↗ |
| K993092 | SONADA ULTRASOUND SYSTEM | Sonovision Corp. | 2000-04-14 | Traditional | PDF ↗ |
| K992506 | MINI 6800 DIGITAL MOBILE C-ARM | Ge Dec Medical Systems | 1999-08-19 | Abbreviated | PDF ↗ |
| K984406 | XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM | Xitec, Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K982706 | PHILIPS BV300 SERIES RELEASE 2.1 | Philips Medical Systems, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K981131 | PATHFINDER MOBILE C ARM | Acoma Medical Imaging, Inc. | 1998-06-26 | Abbreviated | PDF ↗ |
| K980322 | ACCENT 16, ACCENT 22 | GE Medical Systems | 1998-04-24 | Traditional | PDF ↗ |
| K973598 | SIREMOBIL CO2 | Siemens Medical Solutions USA, Inc. | 1997-11-10 | Traditional | PDF ↗ |
| K965013 | DIGISCOPE RX-2 (9 OPTION) | Medirex, Inc. | 1997-01-17 | Traditional | PDF ↗ |
| K963093 | SIREMOBIL COMPACT | Siemens Medical Solutions USA, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K960907 | ORCA | Lunar Corp. | 1996-05-20 | Traditional | PDF ↗ |
| K955251 | OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM | Imaging Services, Inc. | 1996-04-12 | Traditional | PDF ↗ |
| K960198 | DIGISCOPE RX-2 | Medirex, Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K953910 | PHILIPS BV 300 SERIES | Philips Medical Systems North America, Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K951765 | SERIES 6600 DIGITAL MOBILE C-ARM | Ge Dec Medical Systems | 1995-05-11 | Traditional | PDF ↗ |
| K934700 | MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY | Tempo Technology, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K935580 | PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER | Precise Optics | 1994-03-16 | Traditional | PDF ↗ |
| K940294 | SHIMADZU MOBILE X-RAY SYSTEMS | Shimadzu Precision Instruments, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K933431 | ORTHOTRAC COAXIAL LASER | Trac Medical, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K933447 | STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM | GE Medical Systems | 1993-08-23 | Traditional | PDF ↗ |
| K926056 | 9600 FLUOROSCOPIC IMAGING SYSTEM | Oec-Diasonics, Inc. | 1993-01-21 | Traditional | PDF ↗ |
| K914748 | COMET C-125 | Fischer Imaging Corp. | 1992-10-15 | Traditional | PDF ↗ |
| K921255 | PHILIPS BV26 MOBILE C-ARM STAND | Philips Medical Systems, Inc. | 1992-05-18 | Traditional | PDF ↗ |
| K913525 | MOBILE X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K911739 | SWEMAC REISON BIPLANAR 300 | Seemac Reison AB Co. | 1991-10-23 | Traditional | PDF ↗ |
| K910115 | PHILIPS BV-29 IMAGING SYSTEM | Philips Medical Systems, Inc. | 1991-02-20 | Traditional | PDF ↗ |
| K900967 | MODIFIED ALPHA MC-9R C-ARM | Instrumentarium Imaging, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K900193 | MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT | Imt America, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K900194 | MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | Imt America, Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K896387 | SXT-60F/60M MOBILE C ARM X-RAY UNIT | Toshiba America Medical Systems, In.C | 1990-02-23 | Traditional | PDF ↗ |
| K892934 | 1 VIDEO TAPE RECORDER MODEL BK-224 H | Perkins Mfg. Co. | 1989-07-20 | Traditional | PDF ↗ |
| K893617 | MOBILE C-ARM | Acoma Medical Imaging, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K880518 | MOBILE C-ARM OMNI 325 | Fischer Imaging Corp. | 1988-03-09 | Traditional | PDF ↗ |
| K820658 | LIXISCOPE - OR LIXI | Lixi, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K760429 | FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS. | Varian Assoc., Inc. | 1976-08-23 | Traditional | PDF ↗ |
Product code OXO · Class II · Radiology. Data: openFDA.