Search Results

The Biopsy Digit S and SL are intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

The Biopsy Digit S and Biopsy Digit SL are modifications to the Biopsy Digit AM needle guidance system. previously cleared as #K062039. and supplied as an accessory to the Giotto Image 3D/DL mammography system. The CMOS digital camera used on the Biopsy Digit AM is not used on the Biopsy Digit S/SL. Rather a 65mm (high) X 80mm (wide) portion of the full field amorphous selenium detector of the Giotto Image 3D/DL is used to acquire the mammographic, targeting, image data. The mechanics, cleanable surfaces, on-board electronics, and user interface software are all the same as on the biopsy Digit AM. The Biopsy Digit S/SL receives power from the Giotto Image 3D/DL. The Biopsy Digit S/SL in conjunction with the Giotto Image 3D/DL, take two exposures at separate angles ± 22.6° from the perpendicular of the digital detector centerline. The x-ray tube is driven first to one side of center and then to the other by an electro-mechanical mechanism, which is an integral part of the Giotto Image 3D/3DL, so that a stereo pair of images can be acquired. The two views provide two separate 2dimensional projections of the subject anatomy. The two views are stored in the computer system, and can be retrieved and viewed on the computer monitor. The operator, using a mouse, identifies the region of interest on the monitor. The computer then calculates of the region of interest in three dimensions, using trigonometry, and then transfers the coordinates to the needle-positioning unit. The software algorithm used for the calculation is identical to that used by the Biopsy Digit AM (#K062039). The needle-positioning unit then drives the needle holder to the required location so that the operator can insert the needle or locating wire into the exact coordinates necessary.

The intended use of the Giotto Image 3D is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer. The intended use of the Giotto Image 3D-L is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

GIOTTO IMAGE-3DL Full field digital mammography unit with amorphous Selenium detector 24x30. Versatile unit conceived for screening, but ideal for diagnostic. Very low x-ray dose emission, automatic and fast 3D movements of the circular arm, isocentric rotation, prearranged for stereotactic biopsy. x-ray tube with W/Re double track bi-angular anode 10°/16°, 0.1/0.3 mm focal spot, High Frequency/High Power 8 kW generator, Ag/Rh filters with automatic and manual insertion. Double digital display showing rotation and tilting angles of the circular gantry, compression force and compressed thickness. The system includes: - Giotto IMAGE mammography unit with motorized tube rotation ± 24° for . stereotactic biopsy. - Amorphous Selenium detector 24 x 30 cm . - MAW (Management & Acquisition Workstation) ) with 21" LCD 2Mpixel . monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner. - Raffaello® (AWS) software: Graphic User Interface for visualization and . processing of digital mammographic images. DICOM 3 interface. The Giotto Image 3DL consists of gantry with a vertical column, a circular support for the x-ray tube, and compression mechanism, and an x-ray generator all of whip are very similar to the Giotto Image analog mammography system previously cleared under 510(k) K012953. It incorporates an 24 X 30 amorphous selenium detector that directly captures x-rays and converts the them into electronic signal from which the images are constructed. The images are displayed on am monitor for review by the operator. The x-ray tube used is a Varian with tungsten anode and Ag/Rh filters. The gantry can be positioned automatically via motorized movement in 3 dimensions. Images are produced with proprietary acquisition and processing algorithms and displayed at an operator acquisition where the operator may enter patient data (o it is received from a DICOM worklist). The images are transmitted from the acquis (ion station to a workstation for interpretation.

The Biopsy Digit-AM is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy, and guide wire placement.

The BIOPSY DIGIT-AM 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-AM 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.