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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MEDI-6000 MEDICAL IMAGE DIGITIZER

    K Number: K091288 · Decision Aug 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    MEDI-6000 MEDICAL IMAGE DIGITIZER
    K Number
    K091288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microtek International, Inc.
    Date Received
    May 1, 2009
    Decision Date
    August 14, 2009
    Product Code
    LMA
    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
    LMA Digitizer, Image, Radiological

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