Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1650](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1650) → OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile # OXO · Image-Intensified Fluoroscopic X-Ray System, Mobile _Radiology · 21 CFR 892.1650 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO ## Overview - **Product Code:** OXO - **Device Name:** Image-Intensified Fluoroscopic X-Ray System, Mobile - **Regulation:** [21 CFR 892.1650](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1650) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K252579.md) | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | Jan 14, 2026 | SESE | | [K253269](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K253269.md) | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | Nov 26, 2025 | SESE | | [K251004](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K251004.md) | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | Hefei Chimed Intelligent Machine Co., Ltd. | Nov 6, 2025 | SESE | | [K250587](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K250587.md) | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | Jul 2, 2025 | SESE | | [K243452](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K243452.md) | Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. | Jan 14, 2025 | SESE | | [K240828](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K240828.md) | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | Dec 27, 2024 | SESE | | [K233669](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K233669.md) | OEC 3D | Ge Oec Medical Systems, Inc. | Mar 28, 2024 | SESE | | [K213113](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K213113.md) | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | Oct 21, 2021 | SESE | | [K203346](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K203346.md) | OEC 3D | Ge Oec Medical Systems, Inc. | Mar 5, 2021 | SESE | | [K192819](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K192819.md) | OEC Elite | Ge Oec Medical Systems, Inc. | Nov 8, 2019 | SESE | | [K190024](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K190024.md) | Smart-C | Turner Imaging Systems, Inc. | Sep 27, 2019 | SESE | | [K183220](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K183220.md) | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | Jun 21, 2019 | SESE | | [K182626](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K182626.md) | OEC One | Ge Hualun Medical Systems Co. , Ltd. | Nov 16, 2018 | SESE | | [K170946](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K170946.md) | 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K172550.md) | OEC Elite | Ge Oec Medical Systems, Inc. | Nov 16, 2017 | SESE | | [K171800](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K171800.md) | OEC Elite MiniView | Ge Hualun Medical Systems Co. , Ltd. | Jul 12, 2017 | SESE | | [K163429](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K163429.md) | B6 | Beijing East Whale Imaging Technology Co., Ltd. | Jan 4, 2017 | SESE | | [K160984](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K160984.md) | MultiScan G-Arm System | Beijing East Whale Imaging Technology Co., Ltd. | Jul 20, 2016 | SESE | | [K160131](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K160131.md) | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | Jun 21, 2016 | SESE | | [K160065](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO/K160065.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OXO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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