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 a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2025-07-31 under approval 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. It is manufactured by Hologic, Inc.. The 510(k) number is K243341.
When was Genius AI Detection 2.0 approved by the FDA?
Genius AI Detection 2.0 received FDA 510(k) clearance on 2025-07-31, under approval number K243341.
What company makes Genius AI Detection 2.0?
Genius AI Detection 2.0 is manufactured by Hologic, Inc..
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.