FDA 510(k)

AISight Dx

K-Number: K243391 · 2025-06-26

Decision Date2025-06-26

Product CodeQKQ

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

AISight Dx is the device name listed in this FDA 510(k) record. The listed applicant is PathAI, Inc.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) 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. The listed applicant is PathAI, Inc.. The 510(k) number is K243391.

When did AISight Dx receive FDA 510(k) clearance?

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

Who is the listed applicant for AISight Dx?

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

What is the FDA product code for AISight Dx?

The FDA product code for AISight Dx is QKQ.

Other records listing PathAI, Inc. 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.

K212361Novo

Related Devices (Code: QKQ)

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Official Source

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