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510(k) Data Aggregation

    K Number
    K061281
    Device Name
    INSIGHT HEAD COIL
    Date Cleared
    2006-06-19

    (42 days)

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

    INSIGHT NEUROIMAGING SYSTEMS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.
    Device Description
    The Insight Head Coil is a quadrature transmitting and receiving device for use in magnetic resonance imaging of the head regions. This device incorporates advanced radio frequency technology housed in a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patients eyes, nose or mouth. The materials of construction and components are all identical to the predicate devices. The tubular shaped coil is 13" OD x 9.9" ID x 10" L with a section removed from the bottom that is 60° of the coil circumference and 2" deep. The coil is attached to 2 rails that allow it to slide back and away from the patient, and then to be positioned with the patients head inside the tubular device. The back and sides of the coil will be placed over the center of the ears of the patient while the cut out front edge will be placed parallel with the eye brows. The outer surfaces of the coil are manufactured from painted plastic polymer materials. These materials have been found to be biologically inert. These materials are routinely used in medical device construction and can be cleaned using mild bleach or alcohol as the customers will be instructed to do so. The outer surfaces of the coil are manufactured from materials that are routinely used in medical device construction and can be cleaned using mild bleach or alcohol. Features of the Insight Head Coil: Imaging . 2-channel quadrature design uses multiple elements that surround the head tissue . Optimized for high speed imaging applications . Compatible with Siemens and GE3T MRI systems . High SNR Ergonomics . Large ID to accommodate a major percentage of patient population . Ergonomically designed for patient comfort to minimize motion artifact . Positioning accessories include an adjustable head support and retraction mechanism . Attachable mirror to reduce patient claustrophobic response . Complete lack of material in front of the patients face to reduce claustrophobic response.
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