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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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2023-05-23 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K230096.

When did Genius AI Detection 2.0 with CC-MLO Correlation receive FDA 510(k) clearance?

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

Who is the listed applicant for Genius AI Detection 2.0 with CC-MLO Correlation?

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 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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