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

    Dynamyx Digital Pathology Software

    K Number: K210811 · Decision Mar 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    349

    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
    Dynamyx Digital Pathology Software
    K Number
    K210811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inspirata, Inc.
    Date Received
    March 17, 2021
    Decision Date
    March 1, 2022
    Product Code
    QKQ
    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
    QKQ Digital Pathology Image Viewing And Management Software

    Similar 510(k) Clearances

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

    INFINITT DPS

    FDA 510(k)
    FDA Class 2 ·Pathology

    HALO AP Dx

    FDA 510(k)
    FDA Class 2 ·Pathology

    AISight Dx

    FDA 510(k)
    FDA Class 2 ·Pathology

    PathPresenter Clinical Viewer

    FDA 510(k)
    FDA Class 2 ·Pathology

    CaloPix

    FDA 510(k)
    FDA Class 2 ·Pathology

    Viewer+

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