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