← FDA Medical Device Classifications
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
PZC · Not classified · Unknown
Classification
- FDA Product Code
PZC- Device class
- Not classified
- Regulation
- —
- Review panel
- SU
- Medical specialty
- Unknown
- Submission type
- 3
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 4
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown