Surround Medical Systems announced that its Portray dental imaging system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The clearance allows for the system to be sold commercially as a 2D diagnostic tool and allows 3D tomosynthetic and 2D synthetic imaging as adjunctive tools for creating dental images of teeth, jaws, and other structures.
The system aims to allow dentists to detect cavities and fractures that would otherwise go undetected by 2D intraoral dental imaging systems. It will be available to dentists in the last quarter of 2021.
