1 device · 1 company · 2025
Product code OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile
1 device under product code OXO, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Image-Intensified Fluoroscopic X-Ray System, Mobile. 21 CFR 892.1650, Class II. Fluoroscopy of the human body. MAUDE held 10,999 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| OEC One CFDK253269 · 510(k) | Ge Hualun Medical Systems Co. , Ltd. | Radiology | database entry |
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