Indications for Use

FOCALIST™ SYSTEM

Last Updated: July 8, 2025

Indications for Use

The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

Caution: Federal law restricts this device to sale by or on the order of a physician

‍

‍

‍