NRZ — Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided Class III
FDA product code NRZ covers "Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- NRZ
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Unknown
- Implant
- No
Definition
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.