FDA 510(k)

肺AI（LAI001）

K 號：K243239 · 2025-04-24

決定日期2025-04-24

產品代碼MYN

諮詢委員會RA

決定相當於

器材摘要

Lung AI (LAI001) is the device name listed in this FDA 510(k) record. The listed applicant is Exo, Inc.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K243239. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lung AI (LAI001)?

Lung AI (LAI001) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Exo, Inc.. The 510(k) number is K243239.

When did Lung AI (LAI001) receive FDA 510(k) clearance?

Lung AI (LAI001) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K243239.

Who is the listed applicant for Lung AI (LAI001)?

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

What is the FDA product code for Lung AI (LAI001)?

The FDA product code for Lung AI (LAI001) is MYN.

其他以 Exo, Inc. 為申請人之記錄

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相關器械（代碼：MYN）

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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