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510(k) Data Aggregation

    K Number
    K012353
    Device Name
    HNC-127 NEUROVASCULAR ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2001-08-14

    (20 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K062592
    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

    HNC-127 Neurovascular Array Coil (RF coil for Magnetic Resonance Imaging System)

    AI/ML Overview

    I'm sorry, but without further information from the provided text beyond what appears to be a 510(k) clearance letter and an indications for use statement, I cannot answer questions 1 through 9. The provided text is primarily administrative and does not contain details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications.

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