POH · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
POH
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
NE
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device during the procedure.