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 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.

Frequently Asked Questions

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.

Related Devices (Code: POK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.