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The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.

The SureWave Elastography device is an accessory to the MRI system comprised of both hardware and software components. The hardware induces shear wave vibrations in the body through a transducer which is driven by a mobile tower and two flexible rotating axes. The transducer is fastened to the patient's body and contains a rotatable eccentric mass which induces vibrations in the body during an MRI scan. The SureWave Elastography reconstruction software uses the acquired image data from the MRI system to create images that show tissue stiffness.

The Contour Knee is intended for use with Siemens 0.55T MR systems to produce diagnostic images of knee anatomy that can be interpreted by a trained physician.

The Contour Knee is a receive-only, 12-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 0.55T MR systems. The Contour Knee is intended to be used for imaging knee anatomy.

The Flex Body SPEEDER is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities. The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

The Flex Body SPEEDER is intended for use with Canon 3.0T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 3T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities. The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

The Contour 24 is intended for use with Siemens 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 1.5T MR systems. The Contour 24 is intended to be used for imaging general human anatomy, such as the abdomen and pelvis. The Contour 24 is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

The 16ch Foot/Ankle SPEEDER coil is intended for use with Canon 3.0T MR systems to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

The 16ch Foot/Ankle SPEEDER is a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using Canon 3.0T MR systems. The 16ch Foot/Ankle SPEEDER is intended to be used for foot and ankle imaging. The 16ch Foot/Ankle SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in either a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility, or fire-rated flexible flaps that do not come into direct contact but can be easily adjusted to accommodate patients.

The 16ch T/R Hand Wrist Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.

The 16ch T/R Hand Wrist Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 1.5T MR systems. The 16ch T/R Hand Wrist Coil is intended to be used for imaging the hand and wrist. The 16ch T/R Hand Wrist Coil is a reusable, non-invasive device 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 Contour 24 is intended for use with Siemens 3.0T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 3.0T MR systems. The Contour 24 is intended to be used for imaging general human anatomy, such as the abdomen and pelvis. The Contour 24 is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

The 8ch Knee-Foot SPEEDER Coil is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the knee, wrist, hand, foot and ankle that can be interpreted by a trained physician.

The 8ch Knee-Foot SPEEDER coil is a receive-only, 8-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The 8ch Knee-Foot SPEEDER coil is intended to be used for imaging the knee, wrist, hand, foot and ankle. The 8ch Knee-Foot SPEEDER coil is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is flame and impact resistant, and has been tested for biocompatibility. The 8ch Knee-Foot SPEEDER coil also includes the comfort pads listed in Table 10-1, which are provided with the coil shipment.

The 16ch T/R Hand Wrist Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.

The 16ch T/R Hand Wrist Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3.0T MR systems. The 16ch T/R Hand Wrist Coil is intended to be used for imaging the hand and wrist. The 16ch T/R Hand Wrist Coil is a reusable, non-invasive device 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.