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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 the device name listed in this FDA 510(k) record. The listed applicant is Exo Imaging. It received FDA 510(k) clearance on 2024-08-05 under 510(k) 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. The listed applicant is Exo Imaging. The 510(k) number is K240953.

When did AI Platform 2.0 (AIP002) receive FDA 510(k) clearance?

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

Who is the listed applicant for AI Platform 2.0 (AIP002)?

The FDA 510(k) record lists Exo Imaging as the applicant. This does not by itself establish the device manufacturer.

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 records listing Exo Imaging as applicant

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.

Related Devices (Code: QIH)

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.

Official Source

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