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

    X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

    K Number: K243144 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    34
    Applicant Total
    4
    Review Days
    270

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    Basic Information

    Device Name
    X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
    K Number
    K243144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scopio Labs , Ltd.
    Date Received
    September 30, 2024
    Decision Date
    June 27, 2025
    Product Code
    JOY
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOY Device, Automated Cell-Locating

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    Other Clearances by Scopio Labs , Ltd.

    K Number Device Name
    DEN230034 X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
    K220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
    K201301 X100 with Full Field Peripheral Blood Smear (PBS) Application