FDA 510(k)

Seg Pro V3 (RT-300)

K 號：K251306 · 2026-01-28

決定日期2026-01-28

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

Seg Pro V3 (RT-300) is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251306. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Seg Pro V3 (RT-300)?

Seg Pro V3 (RT-300) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K251306.

When did Seg Pro V3 (RT-300) receive FDA 510(k) clearance?

Seg Pro V3 (RT-300) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251306.

Who is the listed applicant for Seg Pro V3 (RT-300)?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Seg Pro V3 (RT-300)?

The FDA product code for Seg Pro V3 (RT-300) is QKB.

其他以 Ever Fortune.Ai, Co., Ltd. 為申請人之記錄

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相關器械（代碼：QKB）

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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