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The intended uses of the Biopsy Digit are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. The intended uses are identical to those of the predicate device.

The Biopsy-Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-Digit they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.

The intended uses of the Biopsy M are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration. needle biopsy and guide wire placement. The intended uses are identical to those of the predicate device.

The Biopsy-M device uses two stereo images on a film to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-M they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.

The Glotto RT is intended to provide film-screen X-ray imaging of the breast and other soft-tissue organs that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto HT can also be used as the imaging device for sterotactic needle biopsy.

The Giotto HT is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film using an x-ray source designed specifically for mammography. It incorporates a state-of-the-art microprocessor controlled high frequency single phase x-ray generator and automatic exposure control, molybdenum rotating anode x-ray tube with 0.3 and 0.1 mm focal spots, gantry, compression device and film holder. The unique open design of the Giotto HT allows positioning of the patient with the operator facing the patient. This face-to-face positioning allows the operator to carefully center the breast and compress it quickly and efficiently. Optional accessories allow both prone and seated breast needle biopsy.