No image
Sonalleve
SONALLEVE MR-HIFU V2 ACHIEVA 3T
Details
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 categoryAblation System, High Intensity Focused Ultrasound (Hifu), Mr Guided, Orthopedic
Device ID07540281000243
Catalog number451000080776
AvailabilityPrescription
MRI safetyMR Conditional