MAGNETIC RESONANCE IMAGING SYSTEM - India CDSCO Medical Device Registration

Product Information

Intended Use: This equipment applies the radio-frequency magnetic field to the patient in magnetic field and receives energy emitted when protons caused nuclear magnetic resonance return to their original state, and reconstructs tomograms of various regions of human body through computer processing. Since it allows us to observe the internal state of all over regions of human body, it is used as diagnostic equipment in various clinical applications. Indication for Use: The ECHELON Smart is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the head and body. The images produced reflect the spatial distribution of protons (MRI) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (MRI), spin-spin relaxation time (MRI), and chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis