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FDA 510(k)

AI Platform (AIP001)

K-Number: K232501 · 2023-11-17

ApplicantExo, Inc.
Decision Date2023-11-17
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI Platform (AIP001) is a medical device manufactured by Exo, Inc.. It received FDA 510(k) clearance on 2023-11-17 under approval number K232501. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI Platform (AIP001)?

AI Platform (AIP001) is a medical device that received FDA 510(k) clearance on 2023-11-17. It is manufactured by Exo, Inc.. The 510(k) number is K232501.

When was AI Platform (AIP001) approved by the FDA?

AI Platform (AIP001) received FDA 510(k) clearance on 2023-11-17, under approval number K232501.

What company makes AI Platform (AIP001)?

AI Platform (AIP001) is manufactured by Exo, Inc..

What is the FDA product code for AI Platform (AIP001)?

The FDA product code for AI Platform (AIP001) is QIH.

Other Devices by Exo, Inc.

K230497Bladder AI (AIBV01) K242359Strain AI (SAI001) K243239Lung AI (LAI001)

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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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