FDA 510(k)

Aurora

K号: K243605 · 2025-01-17

申请人Ge Medical Systems Israel, Functional Imaging

决定日期2025-01-17

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Aurora is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Israel, Functional Imaging. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243605. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aurora?

Aurora is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Ge Medical Systems Israel, Functional Imaging. The 510(k) number is K243605.

When did Aurora receive FDA 510(k) clearance?

Aurora received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243605.

Who is the listed applicant for Aurora?

The FDA 510(k) record lists Ge Medical Systems Israel, Functional Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora?

The FDA product code for Aurora is KPS.

列明Ge Medical Systems Israel, Functional Imaging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。

K241350Clarify DL K241665Omni 传奇

相关器械（代码：KPS）

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

在 FDA 数据库中查看 →

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。