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

    IMATION SE-204 LASER IMAGER

    K Number: K972822 · Decision Nov 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    1
    Review Days
    112

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    Basic Information

    Device Name
    IMATION SE-204 LASER IMAGER
    K Number
    K972822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imation Enterprises Corp.
    Date Received
    July 30, 1997
    Decision Date
    November 19, 1997
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

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