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510(k) Data Aggregation

    K Number
    K223378
    Device Name
    3.0T 16ch AIR AA
    Manufacturer
    GE Healthcare Coils (USA Instruments, Inc.)
    Date Cleared
    2023-01-03

    (57 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Healthcare Coils (USA Instruments, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K182504
    Device Name
    3.0T Air MP M, 3.0T Air MP L
    Manufacturer
    GE Healthcare Coils (USA Instruments, Inc.)
    Date Cleared
    2018-10-12

    (30 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Healthcare Coils (USA Instruments, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K180666
    Device Name
    48CH Head Coil
    Manufacturer
    GE Healthcare Coils (USA Instruments, Inc.)
    Date Cleared
    2018-04-12

    (29 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Healthcare Coils (USA Instruments, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K172695
    Device Name
    AIR Anterior Array, AIR Posterior Array
    Manufacturer
    GE Healthcare Coils (USA Instruments, Inc.)
    Date Cleared
    2017-11-22

    (76 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Healthcare Coils (USA Instruments, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K163205
    Device Name
    48CH Head Coil
    Manufacturer
    GE Healthcare Coils (USA Instruments, Inc.)
    Date Cleared
    2017-01-12

    (58 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Healthcare Coils (USA Instruments, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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 and a custom MEMS (Micro Electro Mechanical System) switch to decouple the receive coil from the MR System body coil. 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.
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