Device Dossier

Stationary panoramic/tomographic dental x-ray system, digital

Device Dossier for Stationary panoramic/tomographic dental x-ray system, digital (Stationary panoramic/tomographic dental x-ray system, digital, Class…

Intended purpose

A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms, zonograms.

TGA Public Summary