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The Breast SPEEDER CX is intended for use with Toshiba 1.5T MRI systems to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. The Grid Holder CX kit is intended for use with the Breast SPEEDER CX to permit access to the breast anatomy for biopsy and lesion localization procedures.

The Breast SPEEDER CX is a receive-only, eight-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The Breast SPEEDER CX is intended to be used for imaging the breast anatomy. Similar to other breast coils, the Breast SPEEDER CX includes apertures through which the breasts are admitted. The Breast SPEEDER CX includes compression plates which allow compression and immobilization of the breast. Breasts may be imaged individually or simultaneously. The Breast SPEEDER CX also includes the accessories listed in Table 0-1. The accessories consist of pads and a head rest intended to increase patient comfort during scanning. The Grid Holder CX Kit is an optional kit offered separately and is intended to be used to allow access to the breast for interventional procedures, such as biopsy and lesion localization. When the Grid Holder CX is used with the Breast SPEEDER CX, the lateral coils are replaced with the biopsy adaptor, which is fitted with either a grid or a post and pillar device, both commercially available. Compatible biopsy grids and post and pillar biopsy devices are available from NORAS MRI Products GmbH and include the items listed in Table 0-2. The breast can be accessed and interventional procedures performed from either the lateral or medial directions. The Breast SPEEDER CX and Grid Holder CX Kit are reusable, noninvasive devices with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.

The Pediatric 16 is intended for use with the Siemens 1.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician.

This filing describes local RF coils intended to be used with the MAGNETOM Aera and Skyra MR systems. The Pediatric 16 is a sixteen-channel receive-only array coil designed for magnetic resonance imaging (MRI) using the Siemens MAGNETOM Aera (1,5T) and Skyra (3T) MR systems. The Pediatric 16 is intended to be used for imaging of the head and neck of neonates and infants.