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

    AUTOMATED MEDICAL REPORT WRITER

    K Number: K981553 · Decision Sep 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    2
    Review Days
    151

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    Basic Information

    Device Name
    AUTOMATED MEDICAL REPORT WRITER
    K Number
    K981553
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Woodson and Associates, LLC
    Date Received
    May 1, 1998
    Decision Date
    September 29, 1998
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Woodson and Associates, LLC

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