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

    3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT

    K Number: K912225 · Decision Jul 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    12
    Review Days
    63

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    Basic Information

    Device Name
    3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT
    K Number
    K912225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Medical Products Group
    Date Received
    May 20, 1991
    Decision Date
    July 22, 1991
    Product Code
    IXW
    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
    IXW Processor, Radiographic-Film, Automatic

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