Device Dossier

Marker, lesion localization, implantable

Device Dossier for Marker, lesion localization, implantable (Marker, lesion localization, implantable, Class IIb, sponsor Signature Orthopaedics). ARTG…

Intended purpose

A device that can be formed as, e.g. a wire, needle or bead that is intended to be implanted either temporarily or permanently within the body in order to create identifying marks that can be seen on film or digital images. This implanted marker is used to locate and delineate a tumour, lesion or other region of interest. It is made from materials that are compatible with the imaging system with which they are intended to be used, e.g. magnetic resonance imaging (MRI), x-ray or nuclear medicine.

TGA Public Summary