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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.
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    K Number
    K143494
    Device Name
    ADX6000 Portable X-Ray System; iRayA6
    Manufacturer
    DEXCOWIN CO., LTD
    Date Cleared
    2015-10-05

    (300 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEXCOWIN CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADX6000 (also known as iRay A6) is a handheld and portable general purpose X-ray system. The device uses a variable tube current with voltage from 50-80 kVp and, therefore, is limited to taking diagnostic x-rays of extremities. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. This device is not intended for mammography.
    Device Description
    The ADX6000 is a portable x-ray system intended to generate and control the emission of xray energy for diagnostic procedures by exposing an x-ray image receptor to ionizing radiation, typically in a hospital or clinic environment. The x-ray source, a tube by Toshiba (tube voltage 50-80kV with 0.8 mm focal spot) is located inside the handheld device. A flat panel detector (FPD), not part of the system, connects to the device via LAN port to enable image capture, manipulation, storage, and transmission through the user interface and device software/firmware. The operator controls three key x-ray variables to obtain the best image at minimal exposure: - 1. Exposure intensity (kV) - 2. Exposure dosage (mA) - 3. Exposure time setting (Sec) The ADX6000 does not have a wireless feature for transmission of data.
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    K Number
    K134055
    Device Name
    ADX4000W
    Manufacturer
    DEXCOWIN CO., LTD
    Date Cleared
    2014-05-09

    (129 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
    The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.
    Device Description
    Not Found
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    K Number
    K133007
    Device Name
    DX3000-L
    Manufacturer
    DEXCOWIN CO., LTD
    Date Cleared
    2014-04-24

    (211 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
    DX3000 is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatic and adult patients using intraoral film or digital sensors
    Device Description
    DX-3000 Portable X-Ray System
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    K Number
    K083532
    Device Name
    ADX4000-L, DX3000-L
    Manufacturer
    DEXCOWIN CO., LTD
    Date Cleared
    2009-03-10

    (102 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
    The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.
    Device Description
    The ADX4000-L, DX3000-L are Cordless Portable Dental X-ray System operated by battery-powered and hand-held dental x-ray machine, This is a prescription device that can be used on pediatric and adult patients.
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