news report
FDA Proposes Class II Path for 3D Breast Scans
The agency would move digital breast tomosynthesis systems from premarket approval to special controls and 510(k) review, while keeping dedicated breast CT in Class III.
topics
Mammography
topics
news report
The agency would move digital breast tomosynthesis systems from premarket approval to special controls and 510(k) review, while keeping dedicated breast CT in Class III.