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The EndoSound Vision System (EVS), when affixed to an endoscope, is intended to provide ultrasonic visualization of, and ultrasound guided therapeutic access to the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The EVS, mounted on an endoscope, is introduced orally when indications consistent with the requirement for a GI procedure are met. The EVS is a prescription only device to be used by a qualified physician. The clinical environments where the system can be used include clinics, hospitals, and ambulatory surgery centers.

The EndoSound Vision System® (EVS) is an add-on ultrasound system designed to attach externally to an upper gastrointestinal (GI) endoscope (gastroscope/upper (EGD) endoscope). Once attached, it temporarily converts an EGD endoscope to a fully capable EUS endoscope. The EVS consists of: - an electronic ultrasound beamformer/image analyzer (EVSScanner), - a reusable transducer assembly (Ultrasound Transducer Module (UTM)), . - . a cable/connector to interface the transducer to the beamformer (Transducer Extension Cable (TEC)). - a sterile, disposable mounting kit with an operator control mechanism (Ultrasound Disposable Kit (UDK-T)) used to externally affix the EVS to a standard gastroscope/upper (EGD) endoscope and to provide needle and transducer angle control. When attached to an upper GI endoscope, the EVS enables real-time ultrasound imaging, ultrasound quided needle aspiration and other EUS quided procedures within the upper gastrointestinal tract and surrounding organs. Native functions of the gastroscope including video imaging, articulation insufflation and suctioning are available after attachment of the EVS device. The system works in tandem with a PC computer/monitor/tablet connected via a USB 3.0 cable that runs custom software (EVSViewer) and provides the user interface and ultrasound display.