FDA 510(k)

Vivid Explorer/Vivid Advanced/Vivid Focus

K 號：K261313 · 2026-09-02

申請人GE Medical Systems Ultrasound and Primary Care Diagnostics

決定日期2026-09-02

產品代碼IYN

諮詢委員會RA

決定Substantially Equivalent

器材摘要

Vivid Explorer/Vivid Advanced/Vivid Focus is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2026-09-02 under 510(k) number K261313. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vivid Explorer/Vivid Advanced/Vivid Focus?

Vivid Explorer/Vivid Advanced/Vivid Focus is a medical device that received FDA 510(k) clearance on 2026-09-02. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K261313.

When did Vivid Explorer/Vivid Advanced/Vivid Focus receive FDA 510(k) clearance?

Vivid Explorer/Vivid Advanced/Vivid Focus received FDA 510(k) clearance on 2026-09-02, under 510(k) number K261313.

Who is the listed applicant for Vivid Explorer/Vivid Advanced/Vivid Focus?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivid Explorer/Vivid Advanced/Vivid Focus?

The FDA product code for Vivid Explorer/Vivid Advanced/Vivid Focus is IYN.

其他以 GE Medical Systems Ultrasound and Primary Care Diagnostics 為申請人之記錄

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相關器械（代碼：IYN）

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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