POH — Mr-Guided Focused Ultrasound System Class III
FDA product code POH covers "Mr-Guided Focused Ultrasound System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- POH
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Unknown
- Implant
- No
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.