Product code PZC
- Device name
- Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.
- Source
- FDA openFDA device classification dataset