FDA-cleared K210670
BU-CAD
TaiHao Medical Inc.
Authorized purpose: Assist trained interpreting physicians in analyzing breast-ultrasound images of patients with soft-tissue breast lesions suspicious for cancer who are referred for further diagnostic ultrasound examination.
- Modality
- Mammography/DBT
- Anatomy
- Breast and suspicious soft-tissue breast lesions.
- Decision
- 2021-12-21