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MrOpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging, MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (72), chemical shift and flow velocity. When interpreted by a trained physician, these images en yield information that can be useful in the determination of a diagnosis,

Like the previously cleared device K101295, the actual MROpen 05 is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV. Modification of K101295 cleared device. - . Remove the angiography limitation, - . update software by adding a new angiography sequence and 3D viewer tool, - update the receiving coils' set including some new coils. . MROpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.