Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
Medical specialty
Unknown
Device class
3
Review panel
OB
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.