OXO · Image-Intensified Fluoroscopic X-Ray System, Mobile
Radiology · 21 CFR 892.1650 · Class 2
Overview
| Product Code | OXO |
|---|---|
| Device Name | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 81)
Showing 20 most recent of 81 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | Jan 14, 2026 | SESE |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | Nov 26, 2025 | SESE |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | Nov 6, 2025 | SESE |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | Jul 2, 2025 | SESE |
| K243452 | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | Jan 14, 2025 | SESE |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | Dec 27, 2024 | SESE |
| K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | Mar 28, 2024 | SESE |
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | Oct 21, 2021 | SESE |
| K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | Mar 5, 2021 | SESE |
| K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | Nov 8, 2019 | SESE |
| K190024 | Smart-C | Turner Imaging Systems, Inc. | Sep 27, 2019 | SESE |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | Jun 21, 2019 | SESE |
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | Nov 16, 2018 | SESE |
| 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 | Nov 24, 2017 | SESE |
| K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | Nov 16, 2017 | SESE |
| K171800 | OEC Elite MiniView | Ge Hualun Medical Systems Co. , Ltd. | Jul 12, 2017 | SESE |
| K163429 | B6 | Beijing East Whale Imaging Technology Co., Ltd. | Jan 4, 2017 | SESE |
| K160984 | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | Jul 20, 2016 | SESE |
| K160131 | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | Jun 21, 2016 | SESE |
| K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System | Gemss Medical Systems Co., Ltd. | May 20, 2016 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 6 clearances
- Beijing East Whale Imaging Technology Co., Ltd. — 5 clearances
- Ge Oec Medical Systems, Inc. — 5 clearances
- Orthoscan, Inc. — 5 clearances
- Ge Hualun Medical Systems Co. , Ltd. — 4 clearances
