Device Dossier

Patient Treatment Kit - Hyperthermia system, ultrasound

Device Dossier for Patient Treatment Kit - Hyperthermia system, ultrasound (Hyperthermia system, ultrasound, Class IIa, sponsor Device Technologies).…

Intended purpose

Accessories to Exablate 4000 system intended to produce and control the delivery of high heat, i.e. temperatures greater than 43 degrees Celsius, to the body for the treatment of malignant or benign tumours, or other disease conditions. It is capable of producing whole body or localized heating effects within tissue or organs using an ultrasonic energy source.

TGA Public Summary