Device Dossier

Digital Radiography System - Computed radiographic system

Device Dossier for Digital Radiography System - Computed radiographic system (Computed radiographic system, Class IIb, sponsor Mindray Medical). ARTG…

Intended purpose

Intended purpose The Digital Radiography System is designed to perform radiographic X-ray examinations on all pediatric and adult patients. Indication for use It is intended for use in chest, abdomen and musculo-skeletal exam. Intended users The targeted clinical users include qualified trained doctors, radiographers, or radiologic technologists (RTs) working in various locations. Intended patient population The Digital Radiography System is designed to perform radiographic X-ray examinations on allpediatric and adult patients. Intended medical conditions The Digital Radiography System is intended to use in radiology department of the hospital, providing information of X-ray images about patient to doctors to make clinical diagnosis. Contra-indications The Digital Radiography System is not intended for mammographic applications. Side-effects None.

TGA Public Summary