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 Nobel Biocare).…

Intended purpose

This is a stationary device that is intended to be used to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). The cone beam 3D imaging system and software solutions assist the dental professional to serve their patients in procedures relating to head and neck diagnostics for assessment including planning treatments, surgical guides, digital models and orthodontic appliances.

TGA Public Summary