BI IMAGE-X EVOLUTION
K号: K160458 · 2016-06-20
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决定日期2016-06-20
产品代码EHD
咨询委员会DE
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决定实质等同
器械摘要
BI IMAGE-X EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Radiotecnologia Industrial S.A. DE C.V.. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K160458. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BI IMAGE-X EVOLUTION?
BI IMAGE-X EVOLUTION is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Radiotecnologia Industrial S.A. DE C.V.. The 510(k) number is K160458.
When did BI IMAGE-X EVOLUTION receive FDA 510(k) clearance?
BI IMAGE-X EVOLUTION received FDA 510(k) clearance on 2016-06-20, under 510(k) number K160458.
Who is the listed applicant for BI IMAGE-X EVOLUTION?
The FDA 510(k) record lists Radiotecnologia Industrial S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BI IMAGE-X EVOLUTION?
The FDA product code for BI IMAGE-X EVOLUTION is EHD.
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：EHD）
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。
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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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