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

    MIPRON/UMIPRON

    K Number: K891689 · Decision Oct 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    3
    Review Days
    219

    Basic Information

    Device Name
    MIPRON/UMIPRON
    K Number
    K891689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    KONTRON ELECTRONICS
    Date Received
    March 22, 1989
    Decision Date
    October 27, 1989
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by KONTRON ELECTRONICS

    K Number Device Name
    K891692 MIP MR
    K892712 MIP/CT IMAGE PROCESSING WORKSTATION