Surround Medical Systems Gets 510(k) Clearance for Dental Imaging System

Morrisville, N.C.-based Surround Medical Systems has been granted the FDA’s 510(k) marketing clearance for its Portray dental imaging system.

The system delivers two-dimensional and 3D tomosynthetic images — which combine multiple x-rays to create a three-dimensional image — to produce diagnostic dental radiographs of teeth, jaws and other oral structures.

The system enables dentists to see tooth decay in its earlier stages and to visually separate teeth that touch, revealing fractures and conditions that were previously invisible or obscured, the company said.