BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

    PMA: P250008 · Decision Mar 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
    Trade Name
    Claire™ OCT System
    PMA Number
    P250008
    Device Class
    FDA Class 3
    Product Code
    SHH
    Generic Name
    OCT imaging system with AI/ML software for adjunctive detection of breast cancer
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 3, 2026
    Date Received
    March 13, 2025
    Expedited Review
    N

    Advisory Committee Statement

    The Claire OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer-aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images. The Claire OCT System is intended for use in conjunction with other standard methods for evaluation of the margins of excised lumpectomy tissue during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.

    Classifications

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

    Product Code Device Name
    SHH Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer