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510(k) Data Aggregation

    K Number
    K251734
    Device Name
    ProVee Video Processing Unit (PV-003)
    Manufacturer
    ProVerum Limited
    Date Cleared
    2025-09-24

    (110 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K190648
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ProVee Video Processing Unit is indicated to power the ProVee System for BPH, and to process and display the live imaging.

    Device Description

    The ProVee VPU is a reusable accessory which supports the ProVee System for BPH in performing according to its intended use. The ProVee VPU receives and processes image signals from the ProVee System for BPH and outputs live imaging onto the integrated display.

    The ProVee VPU is a non-sterile reusable device which is non-patient contacting. The ProVee VPU is cleaned prior to use per the validated cleaning instructions which are provided in the instruction manual.

    AI/ML Overview

    N/A

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