Ultrasound Imaging System - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Ultrasound Imaging System

UID: IMP/MD/2023/000245_cceb3a1070e7216c357a696335b98eec_a9f16a326dabc6cac2200e2df91b52f7

Brand Name

Makoto Intravascular Imaging System

License Holder

NIPRO MEDICAL (INDIA) PRIVATE LIMITED

Device Class

Class C

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.

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Brand: Citrix-LA

Class B