|Trade Name||EXABLATE 2000|
|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 to implement the version 4. 2 software and a new patient table (with other related hardware) that allow for operation of the exablate 2000 system with the general electric 3t magnetic resonance imaging (mri) system. Version 4. 2 software provides for an interleaved mode of operation, elongated focal spots, and a scale-able cooling during.