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The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation times (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning. The Gyrex Esteem 1.5T MRI System is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis. surgery planning, or therapy planning and is used in a clinic or hospital setting. The SW Version 5.0 upgrade does not change or contain any additional indications for use.

The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation times (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning. The major components changed or updated over that described in the predicate device submission are: A higher performance gradient amplifier and a water-cooled gradient that when utilized together provide a peak strength of 29mT/M and a slew rate of 60mT/M/msec, An ECG monitoring unit to allow pulse sequences gated to the cardiac cvcle to provide cardiac and pulmonary images with reduced artifact from heart motion, The addition of a phased array spine RF coil for increased FOV coverage in the z-direction, Additional flexibility added to existing user interface software.

The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.

The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning. The major components changed or updated over that described in he predicate device submission are: - A semi-flexible 4-element receive-only phased array pelvic coil for improved pelvic imaging. - A semi-flexible 4-element receive-only phased array body coil for improved imaging of the liver, kidneys and hips. - Additional receive-only surface coils for imaging the spine, shoulder, pelvis, and temperomandibular joint: - A circular polarized spine coil to increase image performance . in the thoracic and lumbar spine when compared to the lumbar spine coil. - A single loop shoulder coil pair for improved patient comfort . and general utility. Large and small coils for patients of different sizes are provided. - A circular polarized pelvic coil to improve performance in . imaging pelvic anatomy compared to the body coil alone. - A bilateral TMJ coil for specialized imaging of . the temperomandibular joint. In addition, the existing system electronics which contained two RF channels per system has been modified to operate with four RF channels including switching and selection mechanisms for Phased Array operation.