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

    RADIOGRAPHIC FILM CASSETTES

    K Number: K962336 · Decision Jul 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    RADIOGRAPHIC FILM CASSETTES
    K Number
    K962336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1850
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unidex Group, Inc.
    Date Received
    June 17, 1996
    Decision Date
    July 3, 1996
    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 Unidex Group, Inc.

    K Number Device Name
    K962338 RADIOGRAPHIC GRID