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

Cone-beam computed tomography system (CBCT), T2 PLUS is a variation of traditional computed tomography (CT) systems. T2 PLUS system used by dental professionals rotate around the patient, capturing data using a cone-shaped X-ray beam. These data are used to reconstruct a three-dimensional (3D) image of the following regions of the patient’s anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw, and neck); and ears, nose, and throat (“ENT”). This may help with the diagnosis, treatment planning and evaluation of certain conditions. T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians.

TGA Public Summary