Saudi Arabia SFDA registration ME0000004837SFDAA00005
O-Arm O2 Imaging System: BI-700-02000
Saudi Arabia·MD·Medtronic Navigation, Littleton·Class IIbActiveProduct information
Mobile X-Ray System Designed for 2D Fluroscopic and 3D Imaging
Product use
The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.
Device classification
- Risk Class
- Class IIb
- Product Category
- MD
- Product Type
- MD
Registration information
- Registration ID
- ME0000004837SFDAA00005
- Authorization ID
- MDMA-1-2017-1825
- Status
- Active
- Expire Date
- May 26, 2024
Manufacturer
- Manufacturer Name
- Medtronic Navigation, Littleton
Model information
- Model ID(s)
- BI-700-00273
Product accessories
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About this record
Access comprehensive regulatory information for O-Arm O2 Imaging System: BI-700-02000 in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIb device is registered with Saudi Arabia SFDA under registration number ME0000004837SFDAA00005 and manufactured by Medtronic Navigation, Littleton.
This page provides complete registration details including product category (MD), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
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