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/2019/000054_1bc4eba47894dc8ff8a1c7c4f3b2f340_4e0c3544dbc45b8dd73ac1564b0d2c06. This device is marketed under the brand name OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Imaging System

UID: IMP/MD/2019/000054_1bc4eba47894dc8ff8a1c7c4f3b2f340_4e0c3544dbc45b8dd73ac1564b0d2c06

Brand Name

OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is indicated for: • For qualitative and quantitative evaluation of vascular morphology in the coronary arteries • As an adjunct to conventional angiographic procedure to provide an image of vessel lumen and wall structures. • For imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedure. The system further computes and displays various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices

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Imaging System

Brand: O-arm O2 Imaging system

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

Class C