PZC — Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue Class N
FDA product code PZC covers "Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PZC
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.