Device typeImaging lesion localization marker, external, single-use: A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.
FDA categorySystem, X-Ray, Film Marking, Radiographic
Device ID00854623006099
Catalog numberM15SC
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information