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FDA 510(k)

软骨量度

K号: K231351 · 2023-07-13

决定日期2023-07-13
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

Chondral Quant is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Soultions USA, Inc.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K231351. 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 Chondral Quant?

Chondral Quant is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Siemens Medical Soultions USA, Inc.. The 510(k) number is K231351.

When did Chondral Quant receive FDA 510(k) clearance?

Chondral Quant received FDA 510(k) clearance on 2023-07-13, under 510(k) number K231351.

Who is the listed applicant for Chondral Quant?

The FDA 510(k) record lists Siemens Medical Soultions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chondral Quant?

The FDA product code for Chondral Quant is LLZ.

相关临床试验

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列明Siemens Medical Soultions 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。

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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