FDA 510(k)

syngo.CT 心脏规划

K号: K200515 · 2020-03-25

决定日期2020-03-25

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

syngo.CT Cardiac Planning is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Soultions USA, Inc.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K200515. 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 syngo.CT Cardiac Planning?

syngo.CT Cardiac Planning is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Siemens Medical Soultions USA, Inc.. The 510(k) number is K200515.

When did syngo.CT Cardiac Planning receive FDA 510(k) clearance?

syngo.CT Cardiac Planning received FDA 510(k) clearance on 2020-03-25, under 510(k) number K200515.

Who is the listed applicant for syngo.CT Cardiac Planning?

The FDA 510(k) record lists Siemens Medical Soultions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo.CT Cardiac Planning?

The FDA product code for syngo.CT Cardiac Planning is JAK.

列明Siemens Medical Soultions USA, 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。

K231351软骨量度 K191309syngo.via 心血管工作流程 VB40A，Scenium

官方来源

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