Device Dossier

Hand-held intraoral dental x-ray system, digital

Device Dossier for Hand-held intraoral dental x-ray system, digital (Hand-held intraoral dental x-ray system, digital, Class IIb, sponsor Acteon…

Intended purpose

This is a handheld portable diagnostic dental x-ray device that is intended to be used to generate and control x-ray beams. The x-ray beams are used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures.

TGA Public Summary