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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esoph. (non-Cardiac) and Trans-esophageal (Cardiac).

The HDI 1500/SA 8800 system is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color-Flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler, or as a combination of these modes. The HDI 1500/SA 8800 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HDI 1500/SA 8800 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The MPT7-4 transducer is a multi-element ultrasound transducer mounted on a gastroscopic articulating device. The transducer elements are electronically time- and phase-coordinated to generate a steered and focused ultrasound beam, which produces a high-resolution real-time image. The transducer allows a circular continuum of tomographic images within a 185-degree arc without moving the transducer. The MPT7-4 has a transducer array that rotates along an axis perpendicular to the axis of the probe shaft. At 0-degree orientation, the acquired tomographic plane is equivalent to the transverse plane, and at approximately 90-degree orientation, sagittal plane images can be obtained with the transducer array about 30 cm from the patient's teeth. The transducer array can be rotated up to 180 degrees, which provides a mirror image of the 0-degree orientation. Multiple tomographic image planes are continuously selected by rotating the transducer array without significant manipulation of the MPT7-4 transducer. The MPT7-4 transducer is used for cardiac and non-cardiac transesophageal 2D and M-mode imaging, pulsed-wave and continuous-wave Doppler, and Color Doppler imaging. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The Biopsy guides are the same as those previously cleared for the predicate device, ATL's HDI 5000 system (K961459). The operating Modes of HDI 1500/SA 8800 system are B-Mode, M, Color-Flow Doppler, Continuous wave (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, or as a combination of these modes. Mmode uses the sweep display method, which has its images flow from the left to the right on the monitor. The HDI 1500/SA 8800 system supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression, via a Dicom 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.