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FDA 510(k)

Lung AI (LAI001)

K-Number: K243239 · 2025-04-24

ApplicantExo, Inc.
Decision Date2025-04-24
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Lung AI (LAI001)?

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

When was Lung AI (LAI001) approved by the FDA?

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

What company makes Lung AI (LAI001)?

Lung AI (LAI001) is manufactured by Exo, Inc..

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

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

Other Devices by Exo, Inc.

K232501AI Platform (AIP001) K230497Bladder AI (AIBV01) K242359Strain AI (SAI001)

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Official Source

View on FDA Database →

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

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