FDA 510(k)

Stellar 成像系统

K号: K241530 · 2024-08-07

申请人Guangdong Optomedic Technologies, Inc.

决定日期2024-08-07

产品代码GCJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Stellar Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2024-08-07 under 510(k) number K241530. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stellar Imaging System?

Stellar Imaging System is a medical device that received FDA 510(k) clearance on 2024-08-07. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K241530.

When did Stellar Imaging System receive FDA 510(k) clearance?

Stellar Imaging System received FDA 510(k) clearance on 2024-08-07, under 510(k) number K241530.

Who is the listed applicant for Stellar Imaging System?

The FDA 510(k) record lists Guangdong Optomedic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stellar Imaging System?

The FDA product code for Stellar Imaging System is GCJ.

列明Guangdong Optomedic Technologies, 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：GCJ）

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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