PZC

Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue

Product code: PZC
Device name: Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification definition

An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PZC

Classification and pathway per current FDA publications. Data from openFDA (CC0).