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

    CLEON IMAGER

    K Number: K770530 · Decision Apr 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    69
    Review Days
    15

    Basic Information

    Device Name
    CLEON IMAGER
    K Number
    K770530
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1330
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    UNION CARBIDE CORP.
    Date Received
    March 21, 1977
    Decision Date
    April 5, 1977
    Product Code
    JAM
    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
    JAM Scanner, Whole Body, Nuclear

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