PMA
FDA Premarket Approval — full safety and effectiveness review for high-risk or novel devices. The most rigorous FDA pathway, distinct from 510(k) substantial-equivalence clearance.
Why it matters to buyers: Rarer than 510(k) in imaging capital equipment. Hologic Selenia Dimensions 3D tomosynthesis was PMA-approved in 2011 — the first commercial DBT, establishing the regulatory category.
Why it matters to engineers: PMA clinical-study data + manufacturing inspection required. Significantly longer review and higher development cost than 510(k). Approval language is "approved", not "cleared".