uStereo Breast Biopsy Stereotactic Device - Stereotactic biopsy system, diagnostic x-ray, mammography

Intended purpose

This is a device that is intended to provide guidance for interventional purposes (such as biopsy, Pré-surgical localization). It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. It Mammographically identified lesions not visible under ultrasound, most commonly calcifications and less commonly masses, asymmetries and architectural distortions, undergo stereotactic biopsy. This device provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images. This information provides guidance for a variety of interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).This device does not include needles.