FDA product code PZC: Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
PZC is the FDA product code for ablation system, high intensity focus ultrasound (hifu), soft tissue. It is a Not classified device, reviewed by the General and Plastic Surgery panel. Devices under PZC reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.
Classification
| Field | Value |
|---|---|
| Device name | Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue |
| Device class | Not classified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PZC devices
openFDA lists no recalls for product code PZC.
Frequently asked questions
What is FDA product code PZC?
PZC is the FDA product code for ablation system, high intensity focus ultrasound (hifu), soft tissue. It is a Not classified device, reviewed by the General and Plastic Surgery panel.
What device class is PZC?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PZC
- Run a recall and safety report across every PZC manufacturer
- Watch product code PZC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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