News & Event
Barreleye Vis-BUS, KMFDS Class III Medical Device Approval
DATE Dec 4, 2024
Vis-BUS, an AI-based breast ultrasound image analysis solution, has been approved as a Class III medical device by the Ministry of Food and Drug Safety as a breast cancer image computer aided detection/diagnosis software.
Barreleye Vis-BUS is is AI-based software that detects and locates suspicious breast lesions on ultrasound images and provides a malignancy score to assist physicians in diagnosis.
- [Product Name] Breast Cancer Image, Computer Aided Detection/Diagnosis Software, Class III
- [Product License No.] No. Heo24-849
- [Date of Initial Approval] 03 December 2024
- [Validity Period] 03 December 2024 – 02 December 2029
- [Issuer] The Ministry of Food and Drug Safety
- Notice