Product code
PZC: Ablation system, high intensity focus ultrasound (hifu), soft tissue
FDA product code · Not Classified · General & Plastic Surgery
Key facts
| Product code | PZC |
|---|---|
| Device | Ablation system, high intensity focus ultrasound (hifu), soft tissue |
| Device class | Not Classified |
| Review panel | General & Plastic Surgery |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database