Device Dossier

Ultrasound system, imaging, general-purpose

Device Dossier for Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor Fujifilm Sonosite). ARTG…

Intended purpose

The SonoSite Edge Ultrasound system is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of teh human body. Specific clinical applications and exam types include: Ophthalmic, Featal - OB/GYN, Abdominal, intraoperative (abdominal organs and vascular), Intra-operative (Neuro), Paediatric, Small Organ (Breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (conventional, Musculoskeletal (Superficial), Cardiac Adult , Cardiac Paediatric, Trans-oesophageal (cardiac), Peripheral vessel.

TGA Public Summary