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The MedNovel Model AiVUS 1000 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of patient's breast when used with an automatic scanning linear array probe. The device is not intended to be used as a replacement for mammography. It is an adjunct (add on) accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The MedNovel Model AiVUS 1000 system is capable of visually reconstructing the ultrasonic images for review with DICOM type files which will assist the doctor in making diagnoses of any abnormalities detected.

The Model AiVUS 1000 is a transducer guiding adjunct which is intended to work in combination with specified legally marketed Ultrasound Diagnostic System (MyLab Gamma, K161359) and Transducer (SL1543, K132231) and previously released exam tables. The Model AiVUS 1000 system is comprised of a patient scanning system and display system. The Model AiVUS 1000 performs an automatic scan of the breast(s) using a probe guiding mechanism(s) imbedded within the scan module. The imbedded system software plots the path of the automated scan, records the ultrasonic images from paired ultrasound system, and has the capability to both display the real-time B-mode ultrasonic images acquired and after the fact review of the breast exam in DICOM supported file format as a means of providing adjunctive information after a patient obtains a mammogram. This adjunctive information may be useful to physicians wishing to have additional information to make diagnoses of any abnormalities detected. The patient scanning system consists of a scan module and associated assembly and electronics. The scan module is centered above a patient's breast and then performs scanning by using the ultrasound linear transducer arrays. While scanning, the real-time images are acquired by video frame grabber. Acquired images are then reconstructed by the Model AIVUS 1000 system software to display the breast images on the Model AIVUS 1000 display system. The Model AiVUS 1000 display system has two adjustable touch panels and associated assembly and electronics.