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

    TRIMAX RADIOGRAPHIC CASSETTE

    K Number: K980722 · Decision Mar 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    50
    Applicant Total
    5
    Review Days
    27

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    Basic Information

    Device Name
    TRIMAX RADIOGRAPHIC CASSETTE
    K Number
    K980722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1850
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imation Corp.
    Date Received
    February 24, 1998
    Decision Date
    March 23, 1998
    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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