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 J Morita). ARTG…

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 (but not limited to) dental and ear/nose/throat (ENT) applications. This is an all-in-one dental X-ray unit that produces diagnostic images for panoramic, cephalometric, and CBCT evaluation. It is a high resolution, unit that offers a minute voxel size of 80 μm and features a horizontal X-ray beam. Two exposure modes offer control and flexibility with a 360° high definition scan, or a faster 180° rotation.

TGA Public Summary