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510(k) Data Aggregation

    K Number
    K033152
    Device Name
    HAC-12 AND HAC-30 HEAD ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2003-10-10

    (10 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    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 head and neck, that can be interpreted by a trained physician.

    Device Description

    Model HAC-12 and HAC-30 Head Array Coil

    AI/ML Overview

    I am sorry, but there is no information about acceptance criteria or a study proving device performance in the provided text. The document is a clearance letter from the FDA for a device called "HAC-12 and HAC-30 Head Array Coil", indicating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but does not include details about specific performance metrics, studies, or acceptance criteria.

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