Device Dossier

Ultrasound system, imaging, general-purpose

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

Intended purpose

UroMaster® Adventure is an ultrasound system intended to be used by a trained healthcare professional to perform urology ultrasound imaging and human body fluid analysis. UroMaster® Adventure is also intended to be used by a trained urologist or physician for robotic assisted transperineal prostate biopsy under transrectal ultrasound guidance. The robotic assistance system serves as a biopsy needle guide only. The insertion of biopsy needle will be done by the urologists or physicians.

TGA Public Summary