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The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.

The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities. The coil has 16 elements tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T 16ch AIR AA is provided with a P-connector that is compatible with GE Healthcare 3.0T MR systems. The coils have a soft material to conforms to the patient's anatomy and maximize patient comfort.

The NeoCoil 16ch Breast Coils are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended for use by trained medical professionals, in combination with and controlled by compatible 1.5T or 3T/3.0T MRI system software. The NeoCoil 16ch Breast Coils can be used with compatible ancillary components, accessories, and/or devices to provide access to breast anatomy for diagnostic or interventional planning/procedures. When used as intended, the 16ch Breast Coil provides information used by the MRI system to produce diagnostic and/or interventional planning images of the breast, axilla, and chest wall. The images produced are interpreted by medical professionals as part of clinical decision making.

The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components, accessories and comfort pads. The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. The 16ch Breast Coils are intended for use in a manner that is identical to the predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018. The 16ch Breast Coil consists of the following arrays available in 1.5T, 3.0T and 3T field strengths: - Medial Array, Breast Coil - . Lateral Array Left, Breast Coil - Lateral Array Right, Breast Coil ● - . Baseplate Assembly, Breast Coil - Biopsy Array Left, Breast Coil ● - Biopsy Array Right, Breast Coil ● The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head. Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed into tomographic images of the breast, axilla and chest wall anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. Accessories associated with the 16ch Breast Coils include biopsy grids and biopsy drapes. The 1.5T Breast Coil, the 3T 16ch Breast Coil, and the 3.0T 16ch Breast Coil are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation. The 16ch Breast Coil is intended for use in a manner that is identical to the predicate device described in this submission. Proposed labeling is documented in the Instructions for Use manual for the 16ch Breast Coil (NC149IFU-en).

The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals, for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software. The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest. When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The images can be interpreted by medical professionals or facilitate Radiation Therapy (RT) planning.

The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths: - AIR Open Head Neck Posterior 9ch - AIR Open Neck Chest Anterior 7ch - AIR Open Head Anterior 16ch . The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MR Overlay for GE Motus, Kizuna, and GEM as well as the associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner) The 1.5T 32Ch AIR Open Coil Suite and the 3.0T 32Ch AIR Open Coil Suite are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation. The 32Ch AIR Open Coil Suite is intended for use in a manner that is identical to the predicate device described in this submission. Proposed labeling is documented in the Instructions for Use manual for the 32Ch AIR Open Coil Suite (NC139IFU-en).

To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician. To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are receive-only phased array RF coils designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Maqnetic Resonance Imaging (MRI) scanners. The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy. The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.

To be used in conjunction with GEHC 1.5T Nagnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy accessories, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.

The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.

The 3.0T AIR MP M is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen. The 3.0T AIR MP L is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.

The 3.0T AIR MP M is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 20 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP M is provided with P-connectors. The coil has a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place. The 3.0T AIR MP L is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 21 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP L is provided with P-connectors. The coil has a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place.

The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals. The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.

The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads. The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.

The AIR Anterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. When used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging. The nucleus detected is hydrogen. The AIR Posterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. The indications for use include spine. When used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. The nucleus detected is hydrogen.

The AIR Anterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone. The AIR Anterior Array contains 30 elements and the housing of the AIR Anterior Array is made of a soft, pliable material that conforms to the patient's anatomy. The coil is padded with a soft material designed to maximize patient comfort. The AIR Posterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the spine, abdomen, torso, pelvis, prostate, cardiac, hips and long bone. The AIR Posterior Array contains 60 elements and is embedded within the patient table of the MR System.