Mr-Guided Focused Ultrasound System
The MR-Guided Focused Ultrasound System (product code POH) is a Class 3 device that uses high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders, with MR imaging and thermal mapping used to plan and monitor the procedure. Class 3 classification requires Premarket Approval (PMA). The device has no assigned regulation number or formal medical specialty designation and is not an implant or life-sustaining product.
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Basic Information
- Product Code
- POH
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.