FDA 510(k)

SIGNA™ Sprint

K 號：K251399 · 2025-09-11

決定日期2025-09-11

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

SIGNA™ Sprint is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K251399. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SIGNA™ Sprint?

SIGNA™ Sprint is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K251399.

When did SIGNA™ Sprint receive FDA 510(k) clearance?

SIGNA™ Sprint received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251399.

Who is the listed applicant for SIGNA™ Sprint?

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

What is the FDA product code for SIGNA™ Sprint?

The FDA product code for SIGNA™ Sprint is LNH.

其他以 Ge Medical Systems, LLC 為申請人之記錄

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相關器械（代碼：LNH）

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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