Device Dossier

Resona A series - Ultrasound system, imaging, general-purpose

Device Dossier for Resona A series - Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor Mindray…

Intended purpose

It is intended for clinical ultrasound diagnosis and examination. It is intended for use in obstetrics, gynecology, abdominal, pediatric, small organ, musculo-skeletal, cardiac, vascular, urology, nerve, and Cephalic exams. Intended users include doctor, nurse, clinical technologist, radio technologist and ultrasonographer proficient in medicine knowledge. The diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. Intended medical conditions are hospital (e.g., imaging laboratory, emergency room, patient bedside, and operating room), medical clinic, physician’s office or an imaging center.

TGA Public Summary