FDA 510(k)

Biograph Horizon PET/CT

K号: K152880 · 2016-01-12

决定日期2016-01-12

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Biograph Horizon PET/CT 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 2016-01-12 under 510(k) number K152880. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biograph Horizon PET/CT?

Biograph Horizon PET/CT is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K152880.

When did Biograph Horizon PET/CT receive FDA 510(k) clearance?

Biograph Horizon PET/CT received FDA 510(k) clearance on 2016-01-12, under 510(k) number K152880.

Who is the listed applicant for Biograph Horizon PET/CT?

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 Horizon PET/CT?

The FDA product code for Biograph Horizon PET/CT is KPS.

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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相关器械（代码：KPS）

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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