Product code OXO
- Device name
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1650
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Fluoroscopy of the human body.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026-01-14 |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-07-02 |
| K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | 2025-01-14 |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 |
| K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | 2024-03-28 |
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021-10-21 |
| K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | 2021-03-05 |
| K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| K190024 | Smart-C | Turner Imaging Systems, Inc. | 2019-09-27 |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019-06-21 |
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | 2018-11-16 |
| 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 |
| K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017-11-16 |
| K171800 | OEC Elite MiniView | Ge Hualun Medical Systems Co. , Ltd. | 2017-07-12 |
| K163429 | B6 | Beijing East Whale Imaging Technology Co., Ltd. | 2017-01-04 |
| K160984 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2016-07-20 |
| K160131 | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | 2016-06-21 |
| K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System | Gemss Medical Systems Co., Ltd. | 2016-05-20 |
| K151280 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | 2015-09-30 |
| K141672 | DIGIARC 100AU+ | Beijing East Whale Imaging Technology Co., Ltd. | 2014-07-31 |
| K133174 | ORTHOSCAN FD MINI C-ARM | Orthoscan, Inc. | 2014-03-28 |
| K131423 | G-ARM MULTISCAN SYSTEM | Beijing East Whale Imaging Technology Co., Ltd. | 2013-11-07 |
| 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 |
| K121303 | MOBILE C-ARM | Canon Inc. -Medical Equipment Group | 2012-07-26 |
| K120388 | INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | Hologic, Inc. | 2012-04-06 |
| K120613 | OEC 9900 ELITE | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | Orthoscan, Inc. | 2012-01-05 |
| K092564 | O-ARM IMAGING SYSTEM | Medtronic Navigation, Inc. (Littleton) | 2010-06-17 |
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| 08055186671096 | FUJIFILM Healthcare Americas Corporation | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2025-07-02 |
| 08053307591070 | TRIDENT | TECHNIX SPA | 2024-11-06 |
| 08053307591087 | TRIDENT | TECHNIX SPA | 2024-11-06 |
| 08055186670440 | AMRAD Medical | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2022-03-25 |
| 08055186670433 | AMRAD Medical | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2022-03-25 |
| 08055186670426 | AMRAD Medical | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2022-03-25 |
| 08055186670419 | AMRAD Medical | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2022-03-25 |
| 08055186670402 | AMRAD Medical | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2022-03-25 |
| 08055186670396 | AMRAD Medical | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2022-03-25 |
| 08055186670389 | FUJIFILM Healthcare Americas Corporation | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-10-24 |
| 08055186670372 | FUJIFILM Healthcare Americas Corporation | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-10-24 |
| 08055186670334 | FUJIFILM Healthcare Americas Corporation | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-10-24 |
| 08055186670341 | FUJIFILM Healthcare Americas Corporation | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-10-24 |
| 08055186670358 | FUJIFILM Healthcare Americas Corporation | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-10-24 |
| 08055186670365 | FUJIFILM Healthcare Americas Corporation | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-10-24 |
| 08055186670136 | FUJIFILM Medical Systems U.S.A. Inc. | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-09-20 |
| 08055186670112 | FUJIFILM Medical Systems U.S.A. Inc. | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-09-20 |
| 08055186670327 | FUJIFILM Medical Systems U.S.A. Inc. | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-09-20 |
| 08055186670310 | FUJIFILM Medical Systems U.S.A. Inc. | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-09-20 |
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| 08055186670297 | STEPHANIX | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-09-20 |
| 08055186670242 | STEPHANIX | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-09-20 |
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| 08055186670143 | FUJIFILM Medical Systems U.S.A. Inc. | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2021-09-20 |
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| EZIEZIEHM80001 | Ziehm 8000 | Ziehm Imaging GmbH | 2020-03-12 |