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FDA 510(k)

Genius AI Detection 2.0 with CC-MLO Correlation

K-Number: K230096 · 2023-05-23

ApplicantHologic, Inc.
Decision Date2023-05-23
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Genius AI Detection 2.0 with CC-MLO Correlation is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2023-05-23 under approval number K230096. 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 with CC-MLO Correlation?

Genius AI Detection 2.0 with CC-MLO Correlation is a medical device that received FDA 510(k) clearance on 2023-05-23. It is manufactured by Hologic, Inc.. The 510(k) number is K230096.

When was Genius AI Detection 2.0 with CC-MLO Correlation approved by the FDA?

Genius AI Detection 2.0 with CC-MLO Correlation received FDA 510(k) clearance on 2023-05-23, under approval number K230096.

What company makes Genius AI Detection 2.0 with CC-MLO Correlation?

Genius AI Detection 2.0 with CC-MLO Correlation is manufactured by Hologic, Inc..

What is the FDA product code for Genius AI Detection 2.0 with CC-MLO Correlation?

The FDA product code for Genius AI Detection 2.0 with CC-MLO Correlation 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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