POH · Mr-Guided Focused Ultrasound System
· Class 3
Overview
| Product Code | POH |
|---|---|
| Device Name | Mr-Guided Focused Ultrasound System |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P150038 | EXABLATE | Insightec | Jul 11, 2016 | APPR |
Top Applicants
- Insightec — 1 clearance
