Details
Device typeMammographic stereotactic biopsy system: An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
FDA categorySystem, x-ray, mammographic
Device ID15420045512931
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information