BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Reader, Cervical Cytology Slide, Automated

    PMA: P950039 · Supplement: S036 · Decision Apr 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Reader, Cervical Cytology Slide, Automated
    Trade Name
    ThinPrep Integrated Imager
    PMA Number
    P950039
    Supplement Number
    S036
    Device Class
    FDA Class 3
    Product Code
    MNM
    Generic Name
    READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 18, 2018
    Date Received
    July 31, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    18M-1580

    Advisory Committee Statement

    Approval of the Hologic ThinPrep® Integrated Imager. The device uses computer imaging technology to assist in primary cervical cancer screening of ThinPrep® Pap Test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma as well as all other cytologic criteria as defined by the Bethesda System: Terminology for Reporting Results of Cervical Cytology.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MNM Reader, Cervical Cytology Slide, Automated