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 Vatech…

Intended purpose

A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams 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. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail.

TGA Public Summary