BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Galen™ Second Read™

    K Number: K241232 · Decision Jan 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    267

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Galen™ Second Read™
    K Number
    K241232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3750
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ibex Medical Analytics , Ltd.
    Date Received
    May 2, 2024
    Decision Date
    January 24, 2025
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QPN), ordered by most recent decision date.

    Paige Prostate

    FDA 510(k)
    FDA Class 2 ·Pathology
    View all