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The TREX MRI system produces cross-sectional images:

• Anatomical Region: General body anatomy, including head, spine, forso, and extremities
• Nucleus excited: 1H nuclei (Proton)
• Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including spin-lattice relaxation time (T1) spin-spin relaxation time (T2) density of nuclei (p) flow velocity chemical shift (δ)
• Clinical use: Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis.

The TREX MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by three additional RF Coils (Head Coil [quadrature], C-Spine Coil [quadrature], and Knee Coil [linear]) to increase the clinical utility of the TREX MRI in the stationary configuration.

The new quadrature Head Coil (Field Effects P/N 96530-01) will have a smaller diameter of 19 cm. The reduction in diameter will allow for improved coil fill factor, increasing SNR, while maintaining optimal coil uniformity. This new coil will replace the original Head Coil.

The new C-Spine Coil Field Effects P/N 96529-01) is substantially re-designed from the original coil, optimized for Cervical Spine imaging, and reducing the potential for patient anxiety and claustrophobia. This new coil utilizes a proprietary multiple receiver coil design, and will replace the original C-Spine/Knee Special Purpose Coil.

The new Knee Coil (Field Effects P/N 96629-01) utilizes a proprietary solenoid receiver coil design optimized for knee and extremity anatomies, improving coil fill factor, and increased S/N Ratio.

TREX MRI software did not need to be revised in order to support full functionality of these coils.

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1. Table of Acceptance Criteria and Reported Device Performance

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