Device Dossier

Ultrasound system - Ultrasound system, imaging, general-purpose

Device Dossier for Ultrasound system - Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor…

Intended purpose

The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Paediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (paediatric and adult), OB/Gyn and Urology. The ultrasound system also provides the measurement and calculation packages used for clinical diagnosis.

TGA Public Summary