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510(k) Data Aggregation

    K Number
    K964820
    Device Name
    MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
    Manufacturer
    US ASIA INSTRUMENTS, INC.
    Date Cleared
    1997-02-28

    (88 days)

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

    US ASIA INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quadrature Extremity Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Extremity Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
    Device Description
    The Quadrature Extremity Coil consists of two volume RF coil elements in a quadrature design. The elements and circuitry are enclosed in a durable covering made of vinyl naughahyde which is fire rated.
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    K Number
    K964753
    Device Name
    MATRIX 3000 FLEXIBLE SPINE COIL
    Manufacturer
    US ASIA INSTRUMENTS, INC.
    Date Cleared
    1997-02-11

    (76 days)

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

    US ASIA INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexible Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.
    Device Description
    The Flexible Spine Coil consists of two volume RF coil elements in a quadrature design. The elements and associated circuitry are enclosed in a flexible vinyl enclosure housing. The coil is wrapped around the patient and the ends are connected and locked. The coil has a fixed circumference.
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    K Number
    K964531
    Device Name
    PROFILE 70000 QUADRATURE VOLUME NECK COIL
    Manufacturer
    US ASIA INSTRUMENTS, INC.
    Date Cleared
    1997-01-24

    (73 days)

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

    US ASIA INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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