POH

Mr-Guided Focused Ultrasound System

Product code: POH
Device name: Mr-Guided Focused Ultrasound System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device during the procedure.

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

Official FDA classification page: POH

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