FDA 510(k)

SIGNA™ Sprint Select

K 號：K253779 · 2026-02-05

決定日期2026-02-05

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

SIGNA™ Sprint Select 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 2026-02-05 under 510(k) number K253779. 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 Select?

SIGNA™ Sprint Select is a medical device that received FDA 510(k) clearance on 2026-02-05. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253779.

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

SIGNA™ Sprint Select received FDA 510(k) clearance on 2026-02-05, under 510(k) number K253779.

Who is the listed applicant for SIGNA™ Sprint Select?

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 Select?

The FDA product code for SIGNA™ Sprint Select 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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