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510(k) Data Aggregation

    K Number
    K130706
    Device Name
    DUOFLEX COIL SUITE (1.5T)
    Date Cleared
    2013-07-25

    (132 days)

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

    MR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.
    Device Description
    The MR Instruments FC1500G-8R DuoFLEX® Coil Suite includes three different sets of coil paddles and a single, shared preamplifier box (the "Connector Box") with a system connector. One set of coil paddles is a pair of 24cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The second set of paddles is a pair of 10cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The third set of paddles is a single rectangular, interventional coil containing a single planar loop. All of these paddles connect to the same connector box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 1, 5 or 8 channels for imaging.
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    K Number
    K110591
    Device Name
    MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
    Date Cleared
    2011-03-29

    (27 days)

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

    MR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This coil is indicated for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic Resonance Scanner systems to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
    Device Description
    The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are multi-channel receive only coils consisting of 16 RF elements. Each RF element has active and passive blocking networks, and integrated preamplifiers. The MC 1504G-16R RF elements are tuned to 'H at 1.5T (63.9 MHz), while the MC 3004G-16R RF elements are tuned to 'H at 3.0T (127.8 MHz). The coil housing is constructed out of a rigid plastic with an opening for patient viewing and comfort; the head support/base is included with each coil assembly.
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    K Number
    K080820
    Device Name
    TEM 3002G- HN DUAL TUNE HEAD COIL
    Date Cleared
    2008-04-02

    (9 days)

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

    MR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MR Instruments TEM 3002G-HN Dual Tune headcoil is to be used in conjunction with a 3T Magnetic Resonance Imaging system to produce proton ('H) images and spectra of the internal structures of the head. In addition, sodium (20Na) images and spectra may be obtained during the same exam without changing the coil. These images and/or spectral information of the head, when interpreted by a trained physician, may yield information that may assist in diagnosis. This device is for prescription use.
    Device Description
    The TEM 3002G-HN Dual Tune headcoil is a quadrature transmit/receive RF coil tuned to proton ('H) and sodium (22Na) frequencies 3T. The TEM resonant elements and associated matching and quadrature splitting circuitry are enclosed in a rigid plastic housing to prevent any exposure to patient or environment.
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    K Number
    K072931
    Device Name
    MC 3003G-32R HEAD COIL
    Date Cleared
    2007-10-30

    (14 days)

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

    MR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
    Device Description
    The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
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    K Number
    K040937
    Device Name
    TEM 3000 HEAD COIL
    Date Cleared
    2004-04-23

    (11 days)

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

    MR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TEM 3000 head coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000 head coil is compatible with the 3T Magnetom Trio MR scanner manufactured by Siemens Medical Systems.
    Device Description
    The TEM 3000 Head Coil is a 15-element quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent any exposure to patient or environment. The coil housing employs a large open viewing window on the top. The coil design facilitates the scanning of patients with different window on the top: "Ifizes patient comfort and ease of use. Included with the coil housing is a Head Support/Coil Base. It allows the coil to be slid back for better patient access.
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