FDA Product Code OXO: Image-intensified Fluoroscopic X-ray System, Mobile
Fluoroscopy Of The Human Body.
Leading manufacturers include Ziehm-Orthoscan, Inc., Ge Hualun Medical Systems Co. , Ltd. and Ge Oec Medical Systems, Inc..
FDA 510(k) Cleared Image-intensified Fluoroscopic X-ray System, Mobile Devices (Product Code OXO)
About Product Code OXO - Regulatory Context
510(k) Submission Activity
81 total 510(k) submissions under product code OXO since 1976, with 81 receiving FDA clearance (average review time: 91 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OXO have taken an average of 150 days to reach a decision - up from 87 days historically. Manufacturers should account for longer review timelines in current project planning.
OXO devices are reviewed by the Radiology panel. Browse all Radiology devices →