FDA 510(k)

VIVIX-S 4386W (FXRD-4386WA)

K 號：K260820 · 2026-06-18

決定日期2026-06-18

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

VIVIX-S 4386W (FXRD-4386WA) is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260820. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VIVIX-S 4386W (FXRD-4386WA)?

VIVIX-S 4386W (FXRD-4386WA) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K260820.

When did VIVIX-S 4386W (FXRD-4386WA) receive FDA 510(k) clearance?

VIVIX-S 4386W (FXRD-4386WA) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260820.

Who is the listed applicant for VIVIX-S 4386W (FXRD-4386WA)?

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

What is the FDA product code for VIVIX-S 4386W (FXRD-4386WA)?

The FDA product code for VIVIX-S 4386W (FXRD-4386WA) is MQB.

其他以 Vieworks Co., Ltd. 為申請人之記錄

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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相關器械（代碼：MQB）

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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