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

    RADIOGRAPHIC FILM CASSETTE

    K Number: K901013 · Decision Mar 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    50
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    RADIOGRAPHIC FILM CASSETTE
    K Number
    K901013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1850
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Infab Corp.
    Date Received
    March 5, 1990
    Decision Date
    March 28, 1990
    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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    Other Clearances by Infab Corp.

    K Number Device Name
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    K901014 RADIOGRAPHIC INTENSIFYING SCREEN
    K901012 RADIOGRAPHIC GRID
    K896289 RADIATION PROTECTION APRON