Device typeTherapeutic oncological/gynaecological ultrasound system: An assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. It typically consists of a piezoelectric transducer (probe), a water supply/power control unit, operator console and monitoring systems, software, and sometimes a patient table. Optimal patient positioning is achieved using an ultrasound scanner or MRI system.
FDA categoryHigh Intensity Ultrasound System For Prostate Tissue Ablation
Device ID07290019402268
Catalog numberSET001653
AvailabilityPrescription
Single useYes
MRI safetyMR Safe