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FDA 510(k)

SafeCT-29

K号: K153331 · 2016-05-17

决定日期2016-05-17
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

SafeCT-29 is the device name listed in this FDA 510(k) record. The listed applicant is Medic Vision Imaging Solutions. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K153331. 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 SafeCT-29?

SafeCT-29 is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Medic Vision Imaging Solutions. The 510(k) number is K153331.

When did SafeCT-29 receive FDA 510(k) clearance?

SafeCT-29 received FDA 510(k) clearance on 2016-05-17, under 510(k) number K153331.

Who is the listed applicant for SafeCT-29?

The FDA 510(k) record lists Medic Vision Imaging Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeCT-29?

The FDA product code for SafeCT-29 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。

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