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510(k) Data Aggregation

    K Number
    K250687
    Device Name
    Cocoon Solo (DX-7020s)
    Manufacturer
    Dexcowin Global Inc
    Date Cleared
    2025-10-24

    (232 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K173046
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cocoon Solo (DX-7020s) is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatric and adult patients.

    Device Description

    Cocoon Solo (DX-7020s) is a handheld, portable X-ray device designed for dental radiographic examination and diagnosis for pediatric and adult patients by exposing a X-ray image receptor to ionizing radiation.

    The X-ray tube is located inside the device body to be used with conventional film (F-speed or greater film), PSP (Phosphor plates), or digital X-ray sensors.

    The image detectors (an integral part of a fully-functional diagnostic x-ray system) are not part of the submission.

    AI/ML Overview

    N/A

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