|Classification Name||ablation system, high intensity focused ultrasound (hifu), mr-guided|
|Generic Name||magnetic resonance guidedfocused ultrasound|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification of the exablate platform 1) so that the same platform can be used with multiple cradles; and 2) to enable the cradle that has the capability to move the transducer in the anterior and posterior directions be used in the locked position for commercial uterine fibroid treatment.