NRZ

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

Product code: NRZ
Device name: Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.

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

Official FDA classification page: NRZ

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