FDA 510(k)

EFAI PACS 图像归档和通信系统

K号: K211257 · 2021-09-10

决定日期2021-09-10

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

EFAI PACS Picture Archiving and Communication System is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K211257. 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 EFAI PACS Picture Archiving and Communication System?

EFAI PACS Picture Archiving and Communication System is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K211257.

When did EFAI PACS Picture Archiving and Communication System receive FDA 510(k) clearance?

EFAI PACS Picture Archiving and Communication System received FDA 510(k) clearance on 2021-09-10, under 510(k) number K211257.

Who is the listed applicant for EFAI PACS Picture Archiving and Communication System?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI PACS Picture Archiving and Communication System?

The FDA product code for EFAI PACS Picture Archiving and Communication System is LLZ.

列明Ever Fortune.Ai, Co., Ltd.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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