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510(k) Data Aggregation

    K Number
    K013514
    Device Name
    PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2002-01-02

    (72 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the pediatric head and spine, that can be interpreted by a trained physician.

    Device Description

    Model PHSL-63 Pediatric Head and Spine Array Coil

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the Model PHSL-63 Pediatric Head and Spine Array Coil. This letter does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter primarily confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also outlines regulatory requirements and contact information.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design based on the input provided.

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