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The Field Effects MRI system produces cross-sectional images: - Anatomical Region: General body anatomy, including head, spine, torso, 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: lmages may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis - RF Coils: Head - quadrature Cervical Spine - quadrature Lumbar Spine, Thoracic Spine, and Abdomen - quadrature Knee - linear - Image Acquisition Spin Echo Gradient Echo (GE,RGE) Fast Spin Echo (FSE) Fast Dual Echo (FDE) 3D Fast Gradient Echo (3DGE, 3DRGE) Inversion Recovery with Fast Spin Echo (FSE STIR, FSE FLAIR)

Identical to the IMiG-MRI 510(k) K963953. The original IMiG-MRI system was renamed as TREX MRI in 510(k) submission K982157. As a result of changing business arrangements, the TREX MRI is now renamed as the Field Effects MRI System. In addition, following successful FDA determination of substantial equivalence of this 510(k) submission for the Image Processing software, Field Effects will cease commercialization efforts and support for the Field Effects MRI System. Service Support will be available through SMIS (refer to ttem 9, Address of Manufacturing Facilities for SMIS contact information). With the exception of the device modifications identified in this 510(k) submission, and the renaming of the product, the Field Effects MRI System is identical to the original IMiG-MRI system (and to the TREX.MRI). The Field Effects MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by image processing software to increase the clinical utility of the Field Effects MRI System in the stationary configuration.