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510(k) Data Aggregation

    K Number
    K013322
    Device Name
    HAC-420 HEAD ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2001-10-16

    (11 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HAC-420 HEAD ARRAY COIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used in conjunction with a Magnetic Resonance Scanner to produce 16 be abod in confully that can be interpreted by a trained physician.

    Device Description

    Model HAC-420 Head Array Coil

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Magnetic Resonance Imaging System, specifically the HAC-420 Head Array Coil.

    This letter primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and general information but does not contain detailed performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be necessary to answer the questions posed.

    The only performance-related statement is in the "Indications for Use" section, which says: "To be used in conjunction with a Magnetic Resonance Scanner to produce [text is cut off, but likely refers to images] that can be interpreted by a trained physician." This is an intended use statement, not a performance metric or acceptance criterion.

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