Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OXO · Predicate Candidate Screening
82 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
211 days90th percentile
82clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | 2026-06-05 | 249 | 0 |
| K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026-01-14 | 152 | 0 |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 | 58 | 0 |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 | 219 | 0 |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-07-02 | 125 | 0 |
| K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-01-14 | 68 | 0 |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 | 276 | 0 |
| K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | 2024-03-28 | 134 | 2 |
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021-10-21 | 24 | 0 |
| K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | 2021-03-05 | 112 | 2 |
| K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | 2019-11-08 | 38 | 3 |
| K190024 | Smart-C | Turner Imaging Systems, Inc. | 2019-09-27 | 263 | 0 |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019-06-21 | 213 | 0 |
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 | 53 | 0 |
| K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobi | Skanray Technologies Private Limited | 2017-11-24 | 239 | 0 |
| K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017-11-16 | 85 | 3 |
| K171800 | OEC Elite MiniView | Ge Hualun Medical Systems Co. , Ltd. | 2017-07-12 | 26 | 0 |
| K163429 | B6 | Beijing East Whale Imaging Technology Co., Ltd. | 2017-01-04 | 28 | 0 |
| K160984 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2016-07-20 | 104 | 0 |
| K160131 | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | 2016-06-21 | 153 | 0 |
| K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray Syst | Gemss Medical Systems Co., Ltd. | 2016-05-20 | 128 | 0 |
| K151280 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2015-09-30 | 139 | 0 |
| K141672 | DIGIARC 100AU+ | Beijing East Whale Imaging Technology Co., Ltd. | 2014-07-31 | 38 | 0 |
| K133174 | ORTHOSCAN FD MINI C-ARM | Orthoscan, Inc. | 2014-03-28 | 162 | 0 |
| K131423 | G-ARM MULTISCAN SYSTEM | Beijing East Whale Imaging Technology Co., Ltd. | 2013-11-07 | 175 | 0 |
| K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIV | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013-05-17 | 177 | 5 |
| K121303 | MOBILE C-ARM | Canon Inc. -Medical Equipment Group | 2012-07-26 | 86 | 0 |
| K120388 | INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | Hologic, Inc. | 2012-04-06 | 59 | 0 |
| K120613 | OEC 9900 ELITE | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 | 37 | 7 |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | Orthoscan, Inc. | 2012-01-05 | 20 | 0 |
| K092564 | O-ARM IMAGING SYSTEM | Medtronic Navigation, Inc. (Littleton) | 2010-06-17 | 301 | 5 |
| K061873 | VERT-X | Direx Systems Corp. | 2006-08-18 | 46 | 0 |
| K060344 | O-ARM IMAGING SYSTEM | Breakaway Imaging, LLC | 2006-03-29 | 47 | 1 |
| K051754 | ORTHOSCAN, ORTHOSCAN HD | Orthoscan, Inc. | 2005-08-09 | 41 | 0 |
| K051490 | GE OEC EVERVIEW 7500 | Ge Oec Medical Systems, Inc. | 2005-07-07 | 31 | 0 |
| K051133 | ARCADIS AVANTIC | Siemens Medical Solutions USA, Inc. | 2005-06-01 | 29 | 0 |
| K050996 | O-ARM IMAGING SYSTEM | Breakaway Imaging, LLC | 2005-05-05 | 15 | 4 |
| K043379 | SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL W | Shimadzu Corp. | 2005-02-17 | 71 | 0 |
| K041213 | 3DSCOPE | Direx Systems Corp. | 2004-07-22 | 73 | 0 |
| K040347 | SIREMOBIL ISO-C 3D | Siemens Medical Systems, Inc. | 2004-03-09 | 26 | 1 |
| K040066 | SIREMOBILE C06 | Siemens Medical Solutions USA, Inc. | 2004-02-12 | 30 | 2 |
| K033066 | XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM | Xitec Holdings, LLC | 2003-11-12 | 44 | 0 |
| K013426 | MOONRAY MOBILE C-ARM | Simad S.R.L. | 2002-03-26 | 161 | 0 |
| K010762 | PHILIPS BV LIBRA | Philips Medical Systems, Inc. | 2001-04-02 | 19 | 1 |
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM | Ge Oec Medical Systems | 2001-03-12 | 90 | 9 |
| K010393 | APOLLO MOBILE C ARM SYSTEM | Cares Built, Inc. | 2001-03-12 | 32 | 0 |
| K003568 | XISCAN 6000 IMAGING SYSTEM | Xitec, Inc. | 2000-12-27 | 37 | 0 |
| K003266 | SIREMOBIL ISO-C 3D | Siemens Medical Solutions USA, Inc. | 2000-12-01 | 44 | 0 |
| K993092 | SONADA ULTRASOUND SYSTEM | Sonovision Corp. | 2000-04-14 | 211 | 0 |
| K992506 | MINI 6800 DIGITAL MOBILE C-ARM | Ge Dec Medical Systems | 1999-08-19 | 23 | 7 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda