Software
- UID
- IMP/MD/2019/000054_719d067b229178f03bcfa1da4ac4dede_b15c9f25319078ca2c2ca0324382b789
- Device class
- Class B
- 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
- Approving authority
- CDSCO
- Product information
- The AptiVue™ E series software is intended to be used only with compatible OPTIS™ imaging systems. 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
Software is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000054_719d067b229178f03bcfa1da4ac4dede_b15c9f25319078ca2c2ca0324382b789. 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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