FDA 510(k)

syngo.via 心脏介入工作流程

K号: K160317 · 2016-02-29

决定日期2016-02-29

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

syngo.via MI Workflows is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-02-29 under 510(k) number K160317. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the syngo.via MI Workflows?

syngo.via MI Workflows is a medical device that received FDA 510(k) clearance on 2016-02-29. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K160317.

When did syngo.via MI Workflows receive FDA 510(k) clearance?

syngo.via MI Workflows received FDA 510(k) clearance on 2016-02-29, under 510(k) number K160317.

Who is the listed applicant for syngo.via MI Workflows?

FDA 510(k)记录中列出西门子医疗解决方案美国公司（Siemens Medical Solutions USA, Inc.）为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for syngo.via MI Workflows?

The FDA product code for syngo.via MI Workflows is LLZ.

列明Siemens Medical Solutions 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。

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官方来源

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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。