FDA 510(k)

Viz HDS、Viz Volume Plus、Viz ICH+

K 號：K232363 · 2024-02-05

決定日期2024-02-05

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Viz HDS, Viz Volume Plus, Viz ICH+ is the device name listed in this FDA 510(k) record. The listed applicant is Viz. Ai, Inc.. It received FDA 510(k) clearance on 2024-02-05 under 510(k) number K232363. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Viz HDS, Viz Volume Plus, Viz ICH+?

Viz HDS, Viz Volume Plus, Viz ICH+ is a medical device that received FDA 510(k) clearance on 2024-02-05. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K232363.

When did Viz HDS, Viz Volume Plus, Viz ICH+ receive FDA 510(k) clearance?

Viz HDS, Viz Volume Plus, Viz ICH+ received FDA 510(k) clearance on 2024-02-05, under 510(k) number K232363.

Who is the listed applicant for Viz HDS, Viz Volume Plus, Viz ICH+?

The FDA 510(k) record lists Viz. Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viz HDS, Viz Volume Plus, Viz ICH+?

The FDA product code for Viz HDS, Viz Volume Plus, Viz ICH+ is QIH.

其他以 Viz. Ai, Inc. 為申請人之記錄

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相關器械（代碼：QIH）

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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