BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CRONEX LO-DOSE MAMMOGRAPHY

    K Number: K832504 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    33
    Applicant Total
    253
    Review Days
    53

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    Basic Information

    Device Name
    CRONEX LO-DOSE MAMMOGRAPHY
    K Number
    K832504
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    July 21, 1983
    Decision Date
    September 12, 1983
    Product Code
    IWZ
    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
    IWZ Film, Radiographic

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