Device Dossier

Sonablate 500 - Hyperthermia system, ultrasound

Device Dossier for Sonablate 500 - Hyperthermia system, ultrasound (Hyperthermia system, ultrasound, Class IIb, sponsor ACRA Regulatory Services). ARTG…

Intended purpose

Sonablate is intended for the minimally invasive treatment of prostate disease using transrectal ultrasound guided HIFU, high intensity focused ultrasound. Users should note that the treatment parameters are specific to the acoustic properties within the region of the prostate. Use of this device for purposes other than its stated indication has the potential to cause serious injury. The system consists of a console, probe, probe arm, stepper, pump/chiller, and reusable accessories.

TGA Public Summary