NRZ · Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
· Class 3
Overview
| Product Code | NRZ |
|---|---|
| Device Name | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided |
| Device Class | Class 3 |
| Review Panel |
Identification
An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P110039 | EXABLATE | Insightec | Oct 18, 2012 | APPR |
| P040003 | EXABLATE 2000 SYSTEM | Insightec, Ltd. | Oct 22, 2004 | APPR |
Top Applicants
- Insightec — 1 clearance
- Insightec, Ltd. — 1 clearance
