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The intended use of the 16 Ch Multipurpose Coil Variety 1.5T and 3T is, in conjunction with a Magnetic Resonance Scanner, body imaging for diagnostic with a MRI system. It is indicated for use as a diagnostic imaging device transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with similar structure can be taken.

The 16 Ch Multipurpose Coil Variety described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 1.5 T or 3 T. The coil system serves only as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the 16 Ch Multipurpose Coil Variety which are digitized and further processed in the MRT system

The Breast Immobilization and Biopsy Device Models Bl 160-O, Bl 160-PA, and Bl 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.

The BI 160-O, BI 160-PA, and Bl 160-CC device is a breast immobilization and biopsy accessory compatible with breast array coils and has the benefit of shaping the breast tissue into a "brick" shape, through mild compression. This allows for more efficient slice utilization. (i.e., fewer slices are needed to image the same amount of tissue). The needle positioning devices allow the needle to be aimed at the lesion identified on the MR scan. Either MR compatible biopsy needles or MR compatible wire localization needles may be used.