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The device 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 linear array transducer.

The ABUS system, with automated ultrasound im-aging of the breast, gives the radiologist a cost effective solution for reviewing the ultrasound images with the corresponding mammogram. The FFBU Diagnostic Ultrasound System modification represents limited hardware and software changes to the Sponsor's predicate device.

The device 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 linear array transducer. U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations. U-Systems L. 9-5 X W MI-12 Transducer is intended for diagnostic breast examinations.

The FFBU Diagnostic Ultrasound system represents hardware and software changes to the predicate device and changes it to a Track 3 system.

The USI-2000 Diagnostic Ultrasound System is being modified to include an accessory for use with the existing diagnostic ultrasound system. The device 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 linear 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 modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory is intended to provide automated data acquisition of ultrasound breast imaging is based on B-mode ultrasound technique using electronic focusing. High-gain electronics recovers the reflected ultrasound signal which is displayed on a computer screen. The accessory includes a mechanical apparatus for breast image acquisition, a video monitor to display the images, and related software. The patient stands next to system and mammography-like plates compress the breast. Tissue is electronically and mechanically scanned using linear array transducer through thin layer of water and sono-lucent film.

The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs. The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures. The USI Needle Guide accessory is intended for small parts use for breast biopsy.

The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle, or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.

The modified U-2000 is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3 dimensional image processing. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ (breast, thyroid, testes), Peripheral Vascular, Musculo-skeletal Conventional.

The modified U-2000 software provides the capability for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets and multiplaner reformatting capabilities.