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The Comfort EC710 is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Comfort EC710 system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.

The Comfort EC710, a 1.5T MRI System, represents a modification to the previously cleared Echostar Comfort 1.5T MRI system (K141945); both utilize a 1.5T superconducting magnet with a 71cm bore, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images, with a data acquisition system supporting multiple coil elements.

The Echostar Comfort 1.5T MRI System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Echostar Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. The Echostar Comfort 1.5T MRI System and Echostar Spica 1.5T MR system are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis.

The Echostar Comfort 1.5T MRI System represents a modification to the previously cleared Echostar Spica 1.5T MR system (K113511); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including a body coil, head coil, spine coil, cspine (neck) coil, shoulder coil, knee coil, small-4 element torso coil, large-12 element torso coil, wrist coil, medium-8 element torso coil, small flex coil and large flex coil.

The Echostar 1.5T and Echostar Spica 1.5 T MR Systems are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body, including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluid are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis. The device is intended for prescription use only. The Echostar Spica 1.5T MR System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI Images produced by the Echostar Spica system reflect the spatial distribution fo the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. This device is intended for prescription use only.

The Echostar Spica 1.5 T MR System represents a modification to the previously cleared Echostar 1.5 T (K082100); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including, a body coil, head coil, spine coil, c-spine (neck) coil, shoulder coil, knee coil, small - 4 element torso coil, large - 12 element torso coil and wrist coil.

The EchoStar 1.5 T MR System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the EchoStar system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-latice relaxation time (TI), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. This device is intended for prescription use only.

The EchoStar 1.5 T MR System is a whole-body magnetic resonance imaging (MRI) system.