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The Affirm breast biopsy guidance system is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

The Affirm Breast Biopsy Guidance System is used with Selenia Dimensions 2D or with Selenia Dimensions 3D tomosynthesis. Lesion location can be obtained from either 2D stereotactic or 3D tomosynthesis image acquisition. Both stereotactic and 3D localization calculate a three dimensional location for percutaneous placement for biopsy, pre-surgical localization or treatment devices. Safety Features include: Automatic detection of mounting, latching, and connection of biopsy guidance module; C-arm motion disabled if biopsy guidance module is not locked in place; Automatic compression release disabled when biopsy guidance module installed; Motorized movement of biopsy device only under user control; Audible alert if biopsy device motion could result in mechanical interference.

The Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of twodimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

The Digital StereoLoc II is an optional accessory to the Selenia Full Field Digital Mammography System. It is attached to the Selenia to perform stereotactic biopsies and is composed of the following elements: - The Biopsy Unit or Stage used for patient compression and vertical mounting of the . biopsy needle. - The SmartWindow control module for X and Y-axis motion control and Z-axis . positioning guidance. - DSM computer workstation and software for stereotactic targeting. . The breast is compressed between the compression paddle and the carbon fiber breast platform of the biopsy unit. The biopsy unit has its own manual compression mechanism that is independent of the Selenia FFDM compression device. There are two compression knobs; one at each side of the biopsy unit. The Smart Window control module gets the Cartesian coordinates (X, Y, Z) of the target from the DSM workstation. - X and Y motion is motorized. Controlled by the operator via the SmartWindow. . - . Z-axis motion is manual and controlled by the operator.

The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system to produce a device that has specific application in first localizing, and then giving a physician the capacity of performing Fine Needle Aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system.

The Modified 650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnosis mammography involves the production of magnified breast images, crease spot compression views, and the thorough examination of breast determined suspicious through screening mammography by a physician in preparation for biopsy.

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The Modified M-IV Mammography System is intended to produce radiographic images of the breast. It is suitable for reasons of images for initial examination for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for reasons of images for initial examination for Screening mainmography inverves the production of magnified images for more thorough examination of areas of the breast determined suspicious mages for more morough oxamilasses in the sampression views, and the unrough sereening manilies are . . . . . . . production of images used by a physician in preparation for biopsy.

Modified M-IV Mammography System