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…
- GMDN category: Hyperthermia system, ultrasound
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.