De Novo
FDA pathway for novel low / moderate-risk devices without a predicate. Briefer than PMA but more rigorous than 510(k) — establishes a new device class with special controls when no predicate exists.
Why it matters to buyers: Less common in imaging capital equipment; more relevant for AI / software-as-medical-device (SaMD) tools where no precedent exists.
Why it matters to engineers: Establishes a new predicate for future 510(k)s — the first De Novo for a new technology class shapes how subsequent vendors enter.