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510(k) Data Aggregation

    K Number
    K250462
    Date Cleared
    2025-08-11

    (174 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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