Device Dossier

Cone beam computed tomography system, head/neck

Device Dossier for Cone beam computed tomography system, head/neck (Cone beam computed tomography system, head/neck, Class IIb, sponsor SN Family Group).…

Intended purpose

This is a stationary device that is intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It is typically intended for dental diagnostic x-ray images. This is an all-in-one dental X-ray unit that produces diagnostic images for panoramic, cephalometric, and CBCT evaluation.

TGA Public Summary