Suzhou RainMed FlashAngio FFR Coronary Analysis System - HSA Registration DE0508994
Access comprehensive regulatory information for Suzhou RainMed FlashAngio FFR Coronary Analysis System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508994 and owned by Suzhou RainMed Medical Technology Co., Ltd.. The device was registered on February 26, 2024.
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The Coronary Analysis System is intended to quantitatively calculate the Coronary Angiography Fractional Flow Reserve (caFFR) in coronary artery stenosis by conducting vascular segmentation and three-dimensional reconstruction on coronary angiography images (conforming with DICOM3.0 standard) and hemodynamic analysis combing with the aortic pressure measured by disposable blood pressure transducer. It is intended to be used for functional evaluation of coronary artery lesions in adult patient by qualified medical technicians. In clinical practice, coronary artery vessels should be comprehensively evaluated combining with the clinical history, symptoms, other diagnostic results of patients and the professional judgment of clinicians. The present product is applicable for patients with the following symptoms: Stable angina, unstable angina, and clinically suspected myocardial ischemia; The stenosis degree of lumen in coronary artery inspected visually is ≥30% and≤ 90%.