FDA 510(k)

Change Healthcare Stratus Imaging PACS

K号: K241981 · 2024-11-12

决定日期2024-11-12

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Change Healthcare Stratus Imaging PACS is the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Canada Company. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K241981. 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 Change Healthcare Stratus Imaging PACS?

Change Healthcare Stratus Imaging PACS is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Change Healthcare Canada Company. The 510(k) number is K241981.

When did Change Healthcare Stratus Imaging PACS receive FDA 510(k) clearance?

Change Healthcare Stratus Imaging PACS received FDA 510(k) clearance on 2024-11-12, under 510(k) number K241981.

Who is the listed applicant for Change Healthcare Stratus Imaging PACS?

The FDA 510(k) record lists Change Healthcare Canada Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Change Healthcare Stratus Imaging PACS?

The FDA product code for Change Healthcare Stratus Imaging PACS is LLZ.

列明Change Healthcare Canada Company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。

K210719Change Healthcare Anatomical AI K181185Change Healthcare Enterprise Viewer

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。