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The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body as follows: Mode of Operation: B-Mode Clinical Application: Small Organ (breast, thyroid, testes) Abdominal The Sonopsy LA System is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning annular array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes. The system is intended to be used for the real-time ultrasonic guidance of needle aspiration and biopsy procedures of breast lesions. The Sonopsy LA System is indicated for use for the diagnostic ultrasound B-mode imaging of small organs (breast, thyroid, testes) and the abdomen when used with the hand-held linear array scanhead. Prescription Use (Per 21 CFR 801.109)

The Sonopsy LA System provides a means for performing a volumetric scan of the breast to image and determine the position of a suspect target. For biopsy procedures, the Sonopsy LA System allows the alignment of an integral needle guidance device that insures that the needle will sample along a line that includes the determined target. The real-time ultrasound image is aligned such that the scan plane corresponds to the plane that the needle will penetrate, which enables the user to make a determination that the needle penetrated to the target area (by virtue of the real-time image). The system operates in B-mode with an automatic scanning annular array • transducer for breast applications and a hand-held linear array scanhead for small organ and abdominal imaging.