Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K173046
    Device Name
    Cocoon Portable Handheld X-Ray System
    Manufacturer
    Dexcowin Co., Ltd.
    Date Cleared
    2017-10-26

    (28 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dexcowin Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cocoon is a portable X-ray System indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or digital sensors. The Cocoon device is intended for use in dental radiographic examination and diagnosis of the teeth, jaw, and oral structure for both pediatric and adult patients.
    Device Description
    Cocoon Portable X-ray System from Dexcowin Co., Ltd., of Seoul, Korea is a handheld x-ray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country. The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.
    Ask a Question

    Page 1 of 1