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To provide a platform to conduct minimally invasive breast biopsy procedures. A biopsy system, which uses x-ray guidance for stereotactic localization, that allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. The tissue removed will require further evaluation through pathological assessment. The system, in combination with the Kuske Breast Applicator Set and the Comfort Catheter System, can also be used as a table platform to perform Interstitial Brachytherapy procedures. The Kuske Breast Applicator Set and the Comfort Catheter System are stand alone items that do not attach to the system. The table platform is utilized as a means to image the area of interest and to image the template for placement of the catheters.

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The MammoPath can be used with Mammotest® (K861692). Mammotest is a breast biopsy system manufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopath would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy. The MammoPath can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen. Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.

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The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system.

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Adaptation for use on the Mammotest® System tables when the clinician wishes to use the Auto Suture ABBI* System for large core biopsy.

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