Kubec Xpert 80 X射线系统
K号: K210957 · 2021-08-31
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器械摘要
Kubec Xpert 80 Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Kub Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K210957. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Kubec Xpert 80 Radiography System?
Kubec Xpert 80 Radiography System is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Kub Technologies, Inc.. The 510(k) number is K210957.
When did Kubec Xpert 80 Radiography System receive FDA 510(k) clearance?
Kubec Xpert 80 Radiography System received FDA 510(k) clearance on 2021-08-31, under 510(k) number K210957.
Who is the listed applicant for Kubec Xpert 80 Radiography System?
The FDA 510(k) record lists Kub Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kubec Xpert 80 Radiography System?
The FDA product code for Kubec Xpert 80 Radiography System is MWP.
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。
列明Kub Technologies, Inc.为申报人的其他记录
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：MWP）
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。
K230136TrueView 200 Pro-US 样本射线摄影系统（TrueView 200 Pro-US）Compai Healthcare (Suzhou) Co.,LtdK230140TrueView Core 100Pro-US 核心标本射线摄影系统（TrueView Core 100Pro-US）Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) X射线系统Kub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd
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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