Device Dossier

Marker, image identification, manual

Device Dossier for Marker, image identification, manual (Marker, image identification, manual, Class IIa, sponsor Alphatec). ARTG record, intended…

Intended purpose

An object that is manually configured and physically placed within the field of view of a medical diagnostic imaging system, and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. Typically, this device is a surgically invasive radiographic marker used as a radiographic guide to help verify a place where surgery is performed (e.g., starting point of pedicle preparation and screw shank insertion). This device is temporarily used during surgery (not implantable).

TGA Public Summary