Cocoon Portable Handheld X-Ray System

FDA 510(k) K173046 · Dexcowin Co., Ltd.

Substantially Equivalent

510(k) numberK173046

Submission

Device name
Cocoon Portable Handheld X-Ray System
Applicant
Dexcowin Co., Ltd.
Seoul, KR
Received
September 28, 2017
Decision date
October 26, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUH – System, X-Ray, Extraoral Source, Digital
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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More from Dental Imaging Technologies Corporation

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K143494ADX6000 Portable X-Ray System; iRayA6IZL · Traditional 10/05/2015SE
K134055ADX4000WMUH · Special 05/09/2014SE
K133007DX3000-LMUH · Special 04/24/2014SE
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Questions and answers

When was Cocoon Portable Handheld X-Ray System cleared by the FDA?

Cocoon Portable Handheld X-Ray System (K173046) received a 510(k) decision of Substantially Equivalent on October 26, 2017, 28 days after the submission was received.

What is the product code of K173046?

The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.