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FDA 510(k)

RevealAI-Lung

K号: K251769 · 2026-01-30

决定日期2026-01-30
产品代码POK
咨询委员会RA
决定实质等同

器械摘要

RevealAI-Lung is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical Ventures, Inc. Dba Revealdx. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K251769. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RevealAI-Lung?

RevealAI-Lung is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Precision Medical Ventures, Inc. Dba Revealdx. The 510(k) number is K251769.

When did RevealAI-Lung receive FDA 510(k) clearance?

RevealAI-Lung received FDA 510(k) clearance on 2026-01-30, under 510(k) number K251769.

Who is the listed applicant for RevealAI-Lung?

The FDA 510(k) record lists Precision Medical Ventures, Inc. Dba Revealdx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RevealAI-Lung?

The FDA product code for RevealAI-Lung is POK.

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相关器械(代码:POK)

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