FDA 510(k)

Omni 神話

K 號：K241665 · 2024-08-08

申請人Ge Medical Systems Israel, Functional Imaging

決定日期2024-08-08

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

Omni Legend 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 2024-08-08 under 510(k) number K241665. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Omni Legend?

Omni Legend is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Ge Medical Systems Israel, Functional Imaging. The 510(k) number is K241665.

When did Omni Legend receive FDA 510(k) clearance?

Omni Legend received FDA 510(k) clearance on 2024-08-08, under 510(k) number K241665.

Who is the listed applicant for Omni Legend?

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 Omni Legend?

The FDA product code for Omni Legend is KPS.

其他以 Ge Medical Systems Israel, Functional Imaging 為申請人之記錄

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相關器械（代碼：KPS）

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。

官方來源

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