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FDA 510(k)

用于视觉应用的立体3D选项

K号: K152352 · 2016-01-20

决定日期2016-01-20
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Stereo 3D option for Vision Applications is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152352. 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 Stereo 3D option for Vision Applications?

Stereo 3D option for Vision Applications is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is GE Medical Systems SCS. The 510(k) number is K152352.

When did Stereo 3D option for Vision Applications receive FDA 510(k) clearance?

Stereo 3D option for Vision Applications received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152352.

Who is the listed applicant for Stereo 3D option for Vision Applications?

FDA 510(k)记录列出了GE医疗系统SCS为申请人。这本身并不能确立该设备制造商。

What is the FDA product code for Stereo 3D option for Vision Applications?

The FDA product code for Stereo 3D option for Vision Applications is LLZ.

相关临床试验

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列明GE Medical Systems SCS为申报人的其他记录

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相关器械(代码:LLZ)

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。

官方来源

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