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

    PROSTATE MECHANICAL IMAGER

    K Number: DEN100016 · Decision Apr 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    707

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    Basic Information

    Device Name
    PROSTATE MECHANICAL IMAGER
    K Number
    DEN100016
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    876.2050
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Artann Laboratories, Inc.
    Date Received
    May 21, 2010
    Decision Date
    April 27, 2012
    Product Code
    OQT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OQT Prostate Lesion, Documentation, System