FDA product code OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile
OXO is the FDA product code for image-intensified fluoroscopic x-ray system, mobile. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel. FDA has cleared 82 510(k) submissions under OXO, 8 in the last five years, from 47 different applicants. The average 510(k) review took 93 days (median 68); 174 days on average over the last three years. FDA has posted 49 recalls for OXO devices, 9 initiated in the last five years.
Definition
Fluoroscopy of the human body.
Classification
| Field | Value |
|---|---|
| Device name | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class II |
| Regulation | 21 CFR 892.1650 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OXO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 94 |
| 2018 | 1 | 53 |
| 2019 | 3 | 171 |
| 2021 | 2 | 68 |
| 2024 | 2 | 205 |
| 2025 | 4 | 118 |
| 2026 | 2 | 200 |
Compare with all 510(k) review times · Search every OXO clearance
Top OXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 6 | 2005-06-01 |
| Ge Oec Medical Systems, Inc. | 5 | 2024-03-28 |
| Orthoscan, Inc. | 5 | 2021-10-21 |
| Beijing East Whale Imaging Technology Co., Ltd. | 5 | 2017-01-04 |
| Ge Hualun Medical Systems Co. , Ltd. | 4 | 2025-11-26 |
42 more applicants have OXO clearances. See the full list in Caduvo.
Most recent OXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253296 | Allengers Medical Systems Limited | Digital C-ARM with 3D | 2026-06-05 | 249 |
| K252579 | Ziehm-Orthoscan, Inc. | Orthoscan TAU MVP Mini C-Arm System | 2026-01-14 | 152 |
| K253269 | Ge Hualun Medical Systems Co. , Ltd. | OEC One CFD | 2025-11-26 | 58 |
| K251004 | Hefei Chimed Intelligent Machine Co., Ltd. | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | 2025-11-06 | 219 |
| K250587 | Ziehm-Orthoscan, Inc. | Orthoscan TAU Mini C-Arm | 2025-07-02 | 125 |
Recalls for OXO devices
49 product recalls in 25 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2025-03-21.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 11 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code OXO?
OXO is the FDA product code for image-intensified fluoroscopic x-ray system, mobile. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel.
What device class is OXO?
Class II, regulation 21 CFR 892.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXO?
Across 82 cleared submissions the average was 93 days from receipt to decision (median 68).
Which companies have the most OXO clearances?
Siemens Medical Solutions USA, Inc. (6); Ge Oec Medical Systems, Inc. (5); Orthoscan, Inc. (5); Beijing East Whale Imaging Technology Co., Ltd. (5); Ge Hualun Medical Systems Co. , Ltd. (4).
Have OXO devices been recalled?
Yes: 49 product recalls across 25 recall events; the most recent began 2025-03-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OXO
- Run a recall and safety report across every OXO manufacturer
- Watch product code OXO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times