FDA-2026-N-7630 for “Radiology Devices; Reclassification of Digital Breast Tomosynthesis System.” The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval). Since the first approval order for a DBT system, FDA has reviewed and approved 3 additional original PMAs (P130020 (Ref. to demonstrate the imaging characteristics of the DBT system, and software verification, validation, and hazard analysis, and clinical image evaluation. A digital breast tomosynthesis system is a prescription device that is intended to generate digital cross-sectional x-ray images of the breast that can be used for the screening and diagnosis of breast cancer.