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The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images. Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

The ClearVision Nuclear Medicine Imaging System acquires and processes cardiac data including gated and non-gated Single Photon Emission Computed Tomography (SPECT) studies. After completion of an acquisition, the operator can select the resulting acquisition data file to generate both qualitative and quantitative results for review by a physician. This includes processing using Release 5.6 of Segami Corporation's Mirage processing software that was previously cleared under 510(k) number K043441 dated 13-January-2005. The acquisition system consists of either a single or dual small field-of-view detectors with each mounted on top of a tower that contains system electronics. To support the acquisition of SPECT data, the patient chair rotates up to 360 degrees in either clockwise or counterclockwise direction. Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV): - . Each tower can be moved horizontally along rails mounted to the floor plate. - . The patient chair seat pan can be moved side-to-side. - Vertical and a horizontal beam lasers are mounted to side of detector. The ClearVision system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system. The OnePass system's design is optimized for acquiring and processing cardiac first pass data. Firstpass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.

The OnePass Nuclear Medicine Imaging System acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available for processing and analysis. The device consists of a vertical support, a single small FOV detector mounted on an articulating arm, a 15 in. color LCD acquisition display, and an acquisition and processing computer workstation. The OnePass system's small field-of-view (FOV) detector and small system footprint are designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.

The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system. The OnePass system's design is optimized for acquiring and processing cardiac first pass data. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.

The OnePass Nuclear Medicine Imaging Systems acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available to the physician for analysis. The acquisition system consists of a single small field-of-view detector mounted on an articulating arm to allow precise positioning of the detector over the patient's heart. In addition, a vertical lift adjusts the detector height position to track changes in the incline of the treadmill to ensure camera remains positioned directly over the patient's heart during acquisition.