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FDA 510(k)

AISight Dx

K-Number: K243391 · 2025-06-26

ApplicantPathAI, Inc.
Decision Date2025-06-26
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

AISight Dx is a medical device manufactured by PathAI, Inc.. It received FDA 510(k) clearance on 2025-06-26 under approval number K243391. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AISight Dx?

AISight Dx is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by PathAI, Inc.. The 510(k) number is K243391.

When was AISight Dx approved by the FDA?

AISight Dx received FDA 510(k) clearance on 2025-06-26, under approval number K243391.

What company makes AISight Dx?

AISight Dx is manufactured by PathAI, Inc..

What is the FDA product code for AISight Dx?

The FDA product code for AISight Dx is QKQ.

Other Devices by PathAI, Inc.

K212361Novo

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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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