AIRIS

The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination, surgery planning, or therapy monitoring.

In order to ensure the availability for evaluating the accuracy of MRI results, intended patients are those subjects for whom it is anticipated that adequate, independent confirmation of any lesion apparently detected with the MR system can be obtained. With the exception of normal volunteers, eligible patients must have suspected or documented neoplastic, degenerative, infectious, or developmental disease process strongly suspected or established by physical exam, history, or conventional histologic, biochemical, bacteriological, or imaging techniques, or have surgical or aspiration biopsy pending that will be used to establish a diagnosis. The intended patients are primarily drawn from a pool of those subjects undergoing diagnostic evaluation by physicians who are skilled in diagnosis and treatment of the disease process(es) under consideration.