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510(k) Data Aggregation

    K Number
    K250462
    Device Name
    UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
    Manufacturer
    Univlabs Technologies Private Limited
    Date Cleared
    2025-08-11

    (174 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K201135
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UL UHD-Clear View 4K Camera System (UL-3Chip 4K), consisting of a Camera Control Unit and an Endoscopic Camera Head, is indicated for use with compatible endoscopes to provide visualization during general endoscopic procedures. These procedures may involve the visual inspection of internal anatomical structures to support diagnostic or therapeutic interventions. Patient suitability for particular endoscopic procedures must be determined by the responsible physician based on the individual's clinical condition.

    Device Description

    The UL UHD-Clear View 4K Camera System (UL-3Chip-4K) consisting of a Camera Control Unit (CCU) and Endoscopic Camera Head supports video output up to 4K resolution for connection to external medical-grade display monitors. The Camera Control Unit (CCU) processes electronic signals transmitted from an endoscopic camera head and outputs the video signal to an external display monitor.

    AI/ML Overview

    N/A

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