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KMID : 1142220130080010127
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.127 ~ p.132
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The Study on the Development of Performance Evaluation Method for Ultrasound Detection of Coronary Artery Stenosis
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Jo Jeong-Ho
Kim Sang-Woo
Lee Ju-Hwan
Park Sung-Yun
Kim Sung-Min
Choi Byeong-Cheol
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Abstract
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Lately, the westernization of the Korean diet is driving the increase in the death rate caused by cardiovascular disease. The ultrasound examiner for coronary artery stenosis detection overcomes technical limit of the existing cardiovascular diseases diagnosis devices and it shows that more improved diagnostic accuracy through the threedimensional image in intravascular lesion areas. However, there are have trouble in the permission and instrument development because the guideline of ultrasonic examiner for coronary artery stenosis detection’s performance and safety evaluation doesn’t establish systematically. Accordingly, in this study, we present a guideline of ultrasonic examiner for coronary artery stenosis detection in respect of performance and safety evaluation for state of the medical industry in Korea based on ISO, IEC and FDA guideline. The proposed standards for valuation will expect to provide the consistent valuation basis for the domestic manufactured and import company so, it plans the device’s quality improvement and process improvement.
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KEYWORD
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Coronary artery, Ultrasound, IVUS, Performance
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