FDA 510(k)

GBrain MRI

K号: K250416 · 2025-04-11

决定日期2025-04-11

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

GBrain MRI is the device name listed in this FDA 510(k) record. The listed applicant is Galileo Cds, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250416. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GBrain MRI?

GBrain MRI is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Galileo Cds, Inc.. The 510(k) number is K250416.

When did GBrain MRI receive FDA 510(k) clearance?

GBrain MRI received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250416.

Who is the listed applicant for GBrain MRI?

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

What is the FDA product code for GBrain MRI?

The FDA product code for GBrain MRI is QIH.

列明Galileo Cds, 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。

K252362GBrain MRI

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。