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FDA 510(k)

IMACTIS CT 导航系统

K号: K162314 · 2018-04-24

申请人Imactis, Sas
决定日期2018-04-24
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

IMACTIS CT-Navigation system is the device name listed in this FDA 510(k) record. The listed applicant is Imactis, Sas. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K162314. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IMACTIS CT-Navigation system?

IMACTIS CT-Navigation system is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Imactis, Sas. The 510(k) number is K162314.

When did IMACTIS CT-Navigation system receive FDA 510(k) clearance?

IMACTIS CT-Navigation system received FDA 510(k) clearance on 2018-04-24, under 510(k) number K162314.

Who is the listed applicant for IMACTIS CT-Navigation system?

The FDA 510(k) record lists Imactis, Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMACTIS CT-Navigation system?

The FDA product code for IMACTIS CT-Navigation system is JAK.

相关临床试验

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相关器械(代码:JAK)

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。

官方来源

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