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510(k) Data Aggregation

    K Number
    K993233
    Device Name
    OBC-085 BREAST ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    1999-10-15

    (18 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 female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter and an "Indications for Use" statement for an MRI breast array coil. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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