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FDA 510(k)

AI Platform 2.0 (AIP002)

K-Number: K240953 · 2024-08-05

ApplicantExo Imaging
Decision Date2024-08-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI Platform 2.0 (AIP002) is a medical device manufactured by Exo Imaging. It received FDA 510(k) clearance on 2024-08-05 under approval number K240953. 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 2.0 (AIP002)?

AI Platform 2.0 (AIP002) is a medical device that received FDA 510(k) clearance on 2024-08-05. It is manufactured by Exo Imaging. The 510(k) number is K240953.

When was AI Platform 2.0 (AIP002) approved by the FDA?

AI Platform 2.0 (AIP002) received FDA 510(k) clearance on 2024-08-05, under approval number K240953.

What company makes AI Platform 2.0 (AIP002)?

AI Platform 2.0 (AIP002) is manufactured by Exo Imaging.

What is the FDA product code for AI Platform 2.0 (AIP002)?

The FDA product code for AI Platform 2.0 (AIP002) is QIH.

Other Devices by Exo Imaging

K260217AI Platform 2.2 (AIP002)

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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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