Device Dossier

Marker, lesion localization, implantable

Device Dossier for Marker, lesion localization, implantable (Marker, lesion localization, implantable, Class IIb, sponsor Hologic (Australia & New…

Intended purpose

The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.

TGA Public Summary