KFDA Class 3 medical image detection and diagnostic aid SW 'O-View AI'
It is an AI that assists healthcare providers in diagnostic decisions by providing information on the presence of normal and abnormal areas (lung cancer, pneumonia, pulmonary tuberculosis, pneumothorax) in chest X-ray images. It is the first verified AI diagnostic software in Korea that has obtained a Class 3 license from the Ministry of Food and Drug Safety.
O-View AI : [품목명] 3등급 의료영상검출·진단보조소프트웨어 / [품목허가번호] 제허 23-770호 / [최초허가일] 2023-07-11 / [유효기간] 2023-07-11 ~ 2028-07-10 [발급기관] 식품의약품안전처
O-View AI 요양급여대상 관련 근거: 「국민건강보험 요양급여의 기준에 관한 규칙」 제9조의2, 「요양급여대상·비급여대상 여부 확인의 절차와 방법 등에 관한 기준」 제4조
