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510(k) Data Aggregation
K Number
K173046Device Name
Cocoon Portable Handheld X-Ray System
Manufacturer
Dexcowin Co., Ltd.
Date Cleared
2017-10-26
(28 days)
Product Code
MUH
Regulation Number
872.1800Why 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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