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The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.

The Siemens 3.0T PROCURE™ Array Coil interfaces with a 3.0T 16-channel Siemens MRI scanner and provides high-quality images of the reproductive and urological anatomies in an easy-to-position, wearable, and very flexible design. This lightweight SemiFlex™ design facilitates effortless and accurate positioning similar to wearing a diaper and positions the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The enclosure for the antenna set is made of flexible liquid impermeable, biocompatible materials, and the coil is accompanied by disposable liners (USP Class 6 PET) easily changed between patients, should scanning without clothing be desired. The coil design and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission. This phased-array coil also accommodates popular biopsy systems, both delivered via an opening near the anus and/or vagina, neither included in the scope of this submission as they are independently operated and cleared by the FDA.

The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.

The Siemens 3.0T Blanket Array Coil embeds an MRI antenna set within a quilt-like enclosure providing high-quality images of general human anatomy. It is flexible enough to wrap snuggly around small bodies as well as large adult extremities so it can be used to image those challenging regions such as bilateral brachial plexus, bilateral lower extremities, and even heads. This lightweight SemiFlex™ design facilitates effortless and accurate positioning and ensures the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The Blanket Array Coil is an MRI coil contained within a water-resistant case, featuring a soft and cleanable cover. What the patient feels is a lightweight, warm and soothing blanket. What the radiologist sees is a flawless image without compromising comfort. The underlying technology and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission.

The intended use of this PROCURE Array coil family is to provide high-quality images of the reproductive and urological anatomies in an easy-to-position, wearable, and very flexible design. The coil is indicated for use by the order of a physician to be used as an accessory to a General Electric 1.5T or 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.

The PROCURE™ Coil Family interfaces with a 1.5T or 3.0T 8-channel GE MRI scanner and provides high-quality images of the reproductive and urological anatomies in an easy-to-position, wearable, and very flexible design. This lightweight SemiFlex™ design facilitates effortless and accurate positioning similar to wearing a diaper and positions the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The enclosure for the antenna set is made of flexible liquid impermeable, biocompatible materials, and the coil is accompanied by disposable liners (USP Class 6 PET) easily changed between patients, should scanning without clothing be desired. The two coils in the product family are identical in design, construction, materials, and operation, with the exception of resonant frequency. The designs and materials used for manufacture of both coils are identical to standard MRI coil technology that has existed for several years. The coils use similar blocking networks and impedance matching circuits, and they do not transmit energy into the patient, neither predicate nor current submission. This phased array coil also accommodates popular biopsy systems, both delivered via an opening near the anus and/or vagina, neither included in the scope of this submission as they are independently operated and cleared by the FDA

The intended use for this 1.0T 8-channel Neurovascular Coil is to facilitate diagnostic targeting imaging of brain, neck and upper chest that may be interpreted by a trained physician. - To collect image data throughout the region of the head, neck and chest region of the patient using a Philips vertical-field 1.0T MR scanner. - Various regions of the Brain, including brainstem, pituitary, IAC, and orbits, intra cerebral vascular structure, soft tissue of the facial area, arteries between the aortic arch and the Circle of Willis, soft tissue in the anterior neck, pediatric head/neck, cervical spine, long top and brachial plexus, and with the ability to scan feet and ankles.

The 8 individual coils that comprise the ST SENSE NV 8 Array Coil (Neurovascular Array) interface with a 1.0 Tesla, 8-channel Panorama MRI scanner. Between the device and its predicate, there are slight variations in physical size of electrical and physical aspects (to accommodate focus of anatomies) The designs and materials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a rigid housing that disconnects to facilitate both close coupling of the imaging coil's regionof-sensitivity to the anatomy of interest on a patient anatomy, and ease of entry to each patient. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry.

The family is to be used in conjunction with a GE 1.5T and GE 3.0T Magnetic Resonance Scanner, to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions that can be interpreted by a trained physician. The intended use for the device family is to provide MRI antenna sets to facilitate targeting imaging of the orbit region and mandible region. Tissue of the brain and face with emphasis on the orbits, and of the mandible joint of the head.

The devices are a 1.5T Orbit and Mandible Array and a 3.0T Orbit and Mandible Array. The designs and materials used to manufacture each coil are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing is formed by an EVA foam cover around a flexible circuit board. The two devices in this family are identical except for the tuned frequency.

The intended use for the device family is to provide form fitting MRI antenna sets to facilitate targeting imaging of various musculoskeletal extremity regions using a GE 3.0T MRI scanner. The Indications for use are: - Soft tissue and bone imaging of the extremities as allowed by the MRI system. . - Magnetic resonance peripheral angiography.

The individual coils that comprise the Extremity Coil Family interface with a 3.0 Tesla, 8channel MRI scanner. All coils included in the Extremity Set are extremely similar in design, construction, materials and operation. There are slight variations in physical size (to accommodate differing patient sizes), and slight physical housing variations (required to optimize the image quality depending on the extremity anatomy). The designs and matcrials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a semi-rigid housing in conjunction with semi-flexible flaps and/or padding that facilitates close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest on a broad size variation of patient anatomy. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry.

i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system. ii. Magnetic resonance angiography.

The 3.0T Pediatric Head and Spine Array, Catalog #808GE3000, interfaces with the G.E. 3.0 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inouts and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.

i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system. ii. Magnetic resonance angiography.

The 1.5T Pediatric Head and Spine Array, Catalog #808GE1500, interfaces with the G.E. 1.5 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inputs and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.