JLK Inspection announced that its ischemic stroke diagnosis-supporting software JBS-01K has been first approved by Ministry of Food and Drug Safety (MFDS) of South Korea as an AI-based class III computer aided diagnosis system. Caused by a blood clot in patients' brain, ischemic stroke leads them to aftereffects and reduced performance in exercise ability. As South Korea is becoming an aging society, it is expected that the number of ischemic stroke patients will increase rapidly. Ischemic stroke has different treatments and prognosis by its occurrence subtypes, thus it is crucial to identify the stroke subtype. To analyze brain MR images of patients enables exact stroke subtype classification, quick and appropriate treatments, and a better prognosis. JBS-01K is developed by JLK Inspection's own AI technology. It is an AI-based medical image diagnosis-supporting system which assists medical specialists in diagnosing the cause of ischemic stroke more than detecting brain lesions. When brain MR images and atrial fibrillation presence of patients are entered into JBS-01K, this software shows the probability of four ischemic stroke subtypes to support the physicians and their diagnosis. The MFDS of South Korea uses a four-class classification of medical devices by their intended use and potential hazard to human. More specifically, an AI-based medical device is classified according to how the device shows the diagnosis results. 'Computer aided diagnosis software', which analyzes medical images and automatically shows the probability of presence, severity, or condition of the diseases, is classified as class III, while class II includes 'analyzer, medical image, software' and 'computed aided detection system' which shows the area of medical images. JBS-01K is currently the only medical device classified as 'computer aided diagnosis software' (A26430.14) and approved by the MFDS through a large-scale and multi-center clinical trial for safeness and effectiveness.