Ultrasound Imaging System
- UID
- IMP/MD/2023/000245_cceb3a1070e7216c357a696335b98eec_a9f16a326dabc6cac2200e2df91b52f7
- Device class
- Class C
- Brand name
- Makoto Intravascular Imaging System
- License holder
- NIPRO MEDICAL (INDIA) PRIVATE LIMITED
- Approving authority
- CDSCO
- Product information
- 1. The Makoto? Intravascular Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-corecontaining plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. 2. 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.
Ultrasound Imaging System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000245_cceb3a1070e7216c357a696335b98eec_a9f16a326dabc6cac2200e2df91b52f7. This device is marketed under the brand name Makoto Intravascular Imaging System. The license holder is NIPRO MEDICAL (INDIA) PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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