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510(k) Data Aggregation

    K Number
    K260013

    Validate with FDA (Live)

    Device Name
    CVAC Image Processor
    Manufacturer
    Calyxo, Inc.
    Date Cleared
    2026-03-06

    (60 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K233472
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CVAC Image Processor is only to be used with the CVAC Aspiration System to provide treatment and removal of urinary stones (kidney stones, fragments, and dust) and endoscopic examination of the urinary tract and the interior of the kidney.

    Device Description

    The CVAC Image Processor, the subject device, is a software-controlled, reusable and electrical image processor. The CVAC Image Processor is connected to a standard 110V hospital electrical outlet via a provided power cord. The internal carrier board inside the CVAC Image Processor houses the LED control circuit, the display interface, and supports electrical interconnect between the image signal processing module and the System-on-Module (SOM). This allows the CVAC Image Processor to generate a video signal compatible with standard hospital grade external monitors. Accessories provided with the CVAC Image Processor include a HDMI-to-DVI adapter, a HDMI cable, and a power cable. The CVAC Image Processor software is updated to v1.5 in this submission.

    AI/ML Overview

    N/A

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