BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CRONEX LOW ABSORPTION CASSETTE

    K Number: K952891 · Decision Jul 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    50
    Applicant Total
    13
    Review Days
    20

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    Basic Information

    Device Name
    CRONEX LOW ABSORPTION CASSETTE
    K Number
    K952891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1850
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The DU Pont Co.
    Date Received
    June 23, 1995
    Decision Date
    July 13, 1995
    Product Code
    IXA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IXA Cassette, Radiographic Film

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