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

    QuantX

    K Number: DEN170022 · Decision Jul 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    103

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    Basic Information

    Device Name
    QuantX
    K Number
    DEN170022
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.2060
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Quantitative Insights, Inc.
    Date Received
    April 7, 2017
    Decision Date
    July 19, 2017
    Product Code
    POK
    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
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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    Other Clearances by Quantitative Insights, Inc.

    K Number Device Name
    K170195 QuantX