FDA 510(k)

G腦 MRI

K 號：K250416 · 2025-04-11

決定日期2025-04-11

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Galileo Cds, Inc. 為申請人之記錄

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K252362G腦 MRI

相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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