FDA 510(k)

Biograph mMR带syngo MR E11P-AP01系统软件

K号: K200213 · 2020-05-11

决定日期2020-05-11

产品代码OUO

咨询委员会RA

决定实质等同

器械摘要

Biograph mMR with syngo MR E11P-AP01 system software 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 2020-05-11 under 510(k) number K200213. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biograph mMR with syngo MR E11P-AP01 system software?

Biograph mMR with syngo MR E11P-AP01 system software is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K200213.

When did Biograph mMR with syngo MR E11P-AP01 system software receive FDA 510(k) clearance?

Biograph mMR with syngo MR E11P-AP01 system software received FDA 510(k) clearance on 2020-05-11, under 510(k) number K200213.

Who is the listed applicant for Biograph mMR with syngo MR E11P-AP01 system software?

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 Biograph mMR with syngo MR E11P-AP01 system software?

The FDA product code for Biograph mMR with syngo MR E11P-AP01 system software is OUO.

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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