茧状便携式手持X射线系统
K号: K173046 · 2017-10-26
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决定日期2017-10-26
产品代码MUH
咨询委员会DE
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决定实质等同
器械摘要
Cocoon Portable Handheld X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcowin Co., Ltd.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K173046. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cocoon Portable Handheld X-Ray System?
Cocoon Portable Handheld X-Ray System is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Dexcowin Co., Ltd.. The 510(k) number is K173046.
When did Cocoon Portable Handheld X-Ray System receive FDA 510(k) clearance?
Cocoon Portable Handheld X-Ray System received FDA 510(k) clearance on 2017-10-26, under 510(k) number K173046.
Who is the listed applicant for Cocoon Portable Handheld X-Ray System?
The FDA 510(k) record lists Dexcowin Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cocoon Portable Handheld X-Ray System?
The FDA product code for Cocoon Portable Handheld X-Ray System is MUH.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：MUH）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687茧状单机（DX-7020s）Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0（VistaPano S Ceph）；VistaPano S 2.0（VistaPano S）；ProVecta S-Pan Ceph 2.0（ProVecta S-Pan Ceph）；ProVecta S-Pan 2.0（ProVecta S-Pan）VATECH Co., Ltd.K242778X传感器（型号：IOS-A15IF，HDI-15DGF）Qpix Solutions, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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