Imaging System - India CDSCO Medical Device Registration
Imaging System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000467_1bc4eba47894dc8ff8a1c7c4f3b2f340_073add9897a35afb9759e1826e59cfe5. This device is marketed under the brand name O-arm O2 Imaging system. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
O-arm O2 Imaging system
Device Class
Approving Authority
CDSCO
Product Information
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. The O-arm O2 Imaging System is compatible with certain Image Guided Surgery Systems.
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