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The SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography.

SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 consisting of SonoCiné Image Acquisition Station Model 100 and SonoCiné Image Reading Station Model 100. The SonoCiné Image Acquisition Station Model 100 is a probe guiding adjunct to ultrasound systems which have been previously cleared by FDA. The SonoCiné Image Acquisition Station Model 100 uses a servo motor guided arm to control the speed and direction of the ultrasound transducer during breast scanning examinations. In addition, the SonoCiné Image Acquisition Station Model 100 contains a computer which interfaces to the video output of ultrasound system to record and store, electronically, the ultrasound images at reqular time intervals. The SonoCiné Image Reading Station Model 100 is a software product intended to operate on a personal computer with minimum performance configurations. The SonoCiné Image Reading Station Model 100 is a software product intended to allow after-the-fact review of the images obtained and stored by the SonoCiné Image Acquisition Station Model 100.