BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MetaLite DX Digital Pathology Software

    K Number: K240303 · Decision Oct 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    MetaLite DX Digital Pathology Software
    K Number
    K240303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jellox Biotech, Inc.
    Date Received
    February 2, 2024
    Decision Date
    October 28, 2024
    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

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