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

    Paige Prostate

    K Number: DEN200080 · Decision Sep 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    Paige Prostate
    K Number
    DEN200080
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    864.3750
    Medical Specialty
    Pathology
    Decision
    Unknown
    Applicant
    Paige.Ai
    Date Received
    December 31, 2020
    Decision Date
    September 21, 2021
    Product Code
    QPN
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QPN Software Algorithm Device To Assist Users In Digital Pathology

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