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FDA 510(k)

RevealAI-Lung

K-Number: K251769 · 2026-01-30

ApplicantPrecision Medical Ventures, Inc. Dba Revealdx
Decision Date2026-01-30
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the RevealAI-Lung?

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

When was RevealAI-Lung approved by the FDA?

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

What company makes RevealAI-Lung?

RevealAI-Lung is manufactured by Precision Medical Ventures, Inc. Dba Revealdx.

What is the FDA product code for RevealAI-Lung?

The FDA product code for RevealAI-Lung is POK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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