|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 - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the software of the exablate system including enabling movement of the transducer in the anterior and posterior direction. The modified device is referred to as the exablate 2100 v1. 1 with software version 6. 5.
|Post-Approval Study||Show Report Schedule and Study Progress|