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FDA 510(k)

somatom Scope（配备syngo CT VC30-easyIQ版本），SOMATOM Scope Power（配备syngo CT VC30-easyIQ版本）

K号: K151749 · 2016-03-18

申请人Siemens Medical Solutions USA, Inc.
决定日期2016-03-18
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) 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 2016-03-18 under 510(k) number K151749. 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 somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)?

somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K151749.

When did somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) receive FDA 510(k) clearance?

somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) received FDA 510(k) clearance on 2016-03-18, under 510(k) number K151749.

Who is the listed applicant for somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)?

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 somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)?

The FDA product code for somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) is JAK.

相关临床试验

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列明Siemens Medical Solutions USA, Inc.为申报人的其他记录

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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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