Marker, lesion localization, implantable

Intended purpose

The Scout Reflector is intended to be placed percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (Scout System) the Scout Reflector is located and surgically removed with the target tissue. The Scout System is intended only for the nonimaging detection and localization of the Scout Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.