Integrated Intravascular Ultrasound and Near-Infrared Spectroscopy (IVUS + NIRS) - Vietnam Registration 240000757/PCBB-HCM
Access comprehensive regulatory information for Integrated Intravascular Ultrasound and Near-Infrared Spectroscopy (IVUS + NIRS) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000757/PCBB-HCM and manufactured by Infraredx, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH NIPRO SALES VIỆT NAM.
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Device Details
Registration Details
240000757/PCBB-HCM
000.00.19.H29-240405-0003
Makoto Intravascular Imaging System
TVC-MC10, TVC-MC10i
Technical Details
The Makoto Intravascular Imaging System™ is designed to assess intravascular near-infrared arterial wall imaging in patients undergoing invasive coronary angiography. a) The system is designed to detect the core lipid plaque. b) The system aims to assess the core lipid content of the coronary arteries. c) The system aims to identify patients and plaques at increased risk for significant adverse cardiac events. The system is designed to assess intravascular pathological coronary artery disease. a) Intravascular ultrasound imaging is indicated in patients who are candidates for percutaneous coronary intervention.
Dates and Status
Apr 11, 2024