Device Dossier

Stationary panoramic dental x-ray system, digital

Device Dossier for Stationary panoramic dental x-ray system, digital (Stationary panoramic dental x-ray system, digital, Class IIb, sponsor Shimadzu).…

Intended purpose

The digital X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images.

TGA Public Summary