FDA 510(k)

Signa Voyager，Signa Voyager量子

K 號：K192426 · 2019-10-01

申請人Ge Healthcare (Tianjin) Company Limited

決定日期2019-10-01

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

Signa Voyager, Signa Voyager Quantum is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K192426. 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 Voyager, Signa Voyager Quantum?

Signa Voyager, Signa Voyager Quantum is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K192426.

When did Signa Voyager, Signa Voyager Quantum receive FDA 510(k) clearance?

Signa Voyager, Signa Voyager Quantum received FDA 510(k) clearance on 2019-10-01, under 510(k) number K192426.

Who is the listed applicant for Signa Voyager, Signa Voyager Quantum?

The FDA 510(k) record lists Ge Healthcare (Tianjin) Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signa Voyager, Signa Voyager Quantum?

The FDA product code for Signa Voyager, Signa Voyager Quantum is LNH.

其他以 Ge Healthcare (Tianjin) Company Limited 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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