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The BEXCORE Vacuum Assisted Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. - It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. - It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the BEXCORE Vacuum Assisted Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

BEXCORE Vacuum-Assisted Breast Biopsy (hereinafter referred to as VABB) system is 'a set of equipment used for biopsy' composed of a sterilized disposable needle probe unit (hereafter Probe) and an electronic system unit. The electronic system unit consists of a driver and a main controller box (hereafter Main Body for main controller box). A biopsy needle-BXC135, BXC140, BXC145 are the Probes approved separately-is mounted on a driver, and then inserted into a breast. The inserted biopsy needle, powered by the motor in the Main Body of BXS100F, could be rotated or moved forward/backward to cut affected tissue of the breast. The cut tissues are pulled out by vacuum pressure to a filter mesh of Probe connected to the vacuum suction unit of BXS100F's Main Body. At the moment of completing tissue cut, the air supplied from a Main Body to the front part of the biopsy needle makes easy to discharge the cut tissue smoothly.