BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    E1000 Dx Digital Pathology Solution

    K Number: K241717 · Decision Feb 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    259

    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
    E1000 Dx Digital Pathology Solution
    K Number
    K241717
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandon Diagnostics Limited
    Date Received
    June 14, 2024
    Decision Date
    February 28, 2025
    Product Code
    PSY
    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
    PSY Whole Slide Imaging System

    Similar 510(k) Clearances

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

    Philips IntelliSite Pathology Solution 5.1

    FDA 510(k)
    FDA Class 2 ·Pathology

    Roche Digital Pathology Dx

    FDA 510(k)
    FDA Class 2 ·Pathology

    Philips IntelliSite Pathology Solution 5.1

    FDA 510(k)
    FDA Class 2 ·Pathology

    Philips IntelliSite Pathology Solution

    FDA 510(k)
    FDA Class 2 ·Pathology

    Philips IntelliSite Pathology Solution 5.1

    FDA 510(k)
    FDA Class 2 ·Pathology

    Roche Digital Pathology Dx (VENTANA DP 200)

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