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510(k) Data Aggregation

    K Number
    K143389
    Device Name
    3.0T GEM RT Open Array
    Manufacturer
    GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
    Date Cleared
    2015-03-06

    (100 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 GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus and vasculature imaging. The nucleus excited is hydrogen.
    Device Description
    The 3.0T GEM RT Open Array is a receive-only coil designed to provide optimal penetration, uniformity, and signal to noise ratio for the posterior head-neck and brachial plexus. The 3.0T GEM RT Open Array coil is an 8-Channel Phased Array, which is sold as an option to the Oncology Suite that is compatible with the 3.0T GE GEM compatible MR Scanner. The GEM RT Open Array is a posterior coil that comes with a Pconnector that can be plugged into the head end (P2) or foot end (P4) of the 3.0T GEM patient table (K103327). When used with the Oncology suite the GEM RT Open Array coil can be inserted into the GEM cradle at the head end.
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    K Number
    K123327
    Device Name
    1.5T GEM RT OPEN ARRAY
    Manufacturer
    GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
    Date Cleared
    2013-01-11

    (77 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 GEM RT Open Array Coil that is a part of the Oncology Suite is a receive-only RF coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.
    Device Description
    The 1.5T GEM RT Open Array is a receive only 8-Channel 8-element Posterior Phased Array, for use as an option to the Optima MR450w MR Systems with GEM suites. It is a posterior array which can be inserted into the GEM Table cradle (K103335) at either the head or foot end.
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    K Number
    K122174
    Device Name
    PEDIATRIC POSITIONER PAD SET
    Manufacturer
    GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
    Date Cleared
    2012-11-16

    (116 days)

    Product Code
    KXH
    Regulation Number
    892.1830
    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 Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems for positioning of the pediatric patient.
    Device Description
    The Pediatric Positioner Pad Set is a positioning device for pediatric patients used with brain, spine, and neurovascular surface coils in Magnetic Resonance Imaging. It is comprised of foam coated in Polyscan. The Pediatric Positioner Pad Set is comprised of seven components: the Base Pad, the Main Pad, the Child Head Pad, the Infant Head Pad, the two Pad Side Supports, and the Head Strap. The Base Pad rests on the MR System table. The Main Pad is then placed on top of the Base Pad. The patient is positioned on top of the Main Pad. The two Pad Side Supports are secured on either side of the patient via Velcro. Lastly, either the Child Head Pad or Infant Head Pad is used with the Head Strap to hold the patient's head in place. There are two sizes for the head pad to accommodate different patient sizes.
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    K Number
    K103365
    Device Name
    DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
    Manufacturer
    GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
    Date Cleared
    2011-01-12

    (56 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 Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen.
    Device Description
    The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are surface coils used for Magnetic Resonance Imaging. They are tuned to image Proton nuclei in a receive-only configuration. They are comprised of 32 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques. The 16 Ch version uses multiplexers to allow a 32 channel design to be used on 16 Channel systems.
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    K Number
    K101492
    Device Name
    8 CHANNEL CARDIAC PHASED ARRAY COIL
    Manufacturer
    GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
    Date Cleared
    2010-06-23

    (22 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 8 Channel Cardiac Phased Array Coil is a receive-only RF Coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include imaging of the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. The nucleus excited is hydrogen.
    Device Description
    The 8 Channel Cardiac Phased Array Coil is a surface coil used for Magnetic Resonance Imaging. It is tuned to image Proton nuclei in a receive-only configuration. It is comprised of individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.
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    K Number
    K093348
    Device Name
    3.0T 16 CHANNEL HEAD NECK SPINE COIL
    Manufacturer
    GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
    Date Cleared
    2009-11-25

    (29 days)

    Product Code
    MOS, 90M
    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 GE 3.0T 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.0T MRI system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic, and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.
    Device Description
    The 3.0T Head Neck and Spine Coil is a receive-only 16-channel, 29-element coil designed for use with GE 3.0T MRI Systems. This rigid coil incorporates soft, flexible components that conform to patients' anatomy, accommodating various body contours while minimizing patient discomfort. The Head, Neck and Spine Array (HNS) coil is comprised of 4 units: the Head/ Neck Unit (HNU), the Thoracic/ Lumbar unit (TLU) and the Neck Chest Unit (NCU) and Horseshoe. The 3.0T HNS Coil has an array of 21 coil elements in the head neck units and 8 coil elements in the Spine Unit. Twelve coil elements cover the head region. Another four coil elements cover the lower neck and Brachial Plexus regions. Five coil elements cover the upper neck and the chest region. The Spine Unit has an array of 8 coil elements, which cover the thoracic and lumbar spine regions. The 3.0T 16 Channel Head Neck Spine Coil is a multi-element phased array RF Receive only coil with integrated preamplifiers. The coil design consists of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission.
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