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

    ArteraAI Breast

    K Number: K254115 · Decision May 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    136

    Basic Information

    Device Name
    ArteraAI Breast
    K Number
    K254115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3755
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Artera, Inc.
    Date Received
    December 19, 2025
    Decision Date
    May 4, 2026
    Product Code
    SHW
    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
    SHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

    Other Clearances by Artera, Inc.

    K Number Device Name
    DEN240068 ArteraAI Prostate