FDA 510(k)

V5med 肺部AI

K 號：K242919 · 2025-03-27

決定日期2025-03-27

產品代碼OEB

諮詢委員會RA

決定相當於

器材摘要

V5med Lung AI is the device name listed in this FDA 510(k) record. The listed applicant is V5med, Inc.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K242919. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the V5med Lung AI?

V5med Lung AI is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is V5med, Inc.. The 510(k) number is K242919.

When did V5med Lung AI receive FDA 510(k) clearance?

V5med Lung AI received FDA 510(k) clearance on 2025-03-27, under 510(k) number K242919.

Who is the listed applicant for V5med Lung AI?

The FDA 510(k) record lists V5med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V5med Lung AI?

The FDA product code for V5med Lung AI is OEB.

相關器械（代碼：OEB）

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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