Australia TGA ARTG recordMakoto Intravascular Imaging System - Ultrasound system, imaging, cardiovascular
Australia TGA ARTG Registered Device · Nipro Australia Pty Ltd · Infraredex Inc · Class IIa · Started February 04, 2022
Good Name: Nipro Australia Pty Ltd - Makoto Intravascular Imaging System - Ultrasound system, imaging, cardiovascular
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- February 04, 2022
- Effective Date
- February 04, 2022
- Name
- Infraredex Inc
- Country
- United States of America
- Address
- 28 Crosby Drive Suite 100, Bedford, MA, 01730
The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. The System is intended for ultrasound examination of coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Access comprehensive regulatory information for Makoto Intravascular Imaging System - Ultrasound system, imaging, cardiovascular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Nipro Australia Pty Ltd, manufactured by Infraredex Inc in United States of America. The device registration started on February 04, 2022.
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