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FDA 510(k)

Genius AI Detection 2.0

K-Number: K243341 · 2025-07-31

ApplicantHologic, Inc.
Decision Date2025-07-31
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Genius AI Detection 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243341. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genius AI Detection 2.0?

Genius AI Detection 2.0 is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Hologic, Inc.. The 510(k) number is K243341.

When did Genius AI Detection 2.0 receive FDA 510(k) clearance?

Genius AI Detection 2.0 received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243341.

Who is the listed applicant for Genius AI Detection 2.0?

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

What is the FDA product code for Genius AI Detection 2.0?

The FDA product code for Genius AI Detection 2.0 is QDQ.

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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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