Genius AI Detection
K-Number: K201019 · 2020-11-18
ApplicantHologic, Inc.
Decision Date2020-11-18
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Genius AI Detection is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2020-11-18 under approval number K201019. 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?
Genius AI Detection is a medical device that received FDA 510(k) clearance on 2020-11-18. It is manufactured by Hologic, Inc.. The 510(k) number is K201019.
When was Genius AI Detection approved by the FDA?
Genius AI Detection received FDA 510(k) clearance on 2020-11-18, under approval number K201019.
What company makes Genius AI Detection?
Genius AI Detection is manufactured by Hologic, Inc..
What is the FDA product code for Genius AI Detection?
The FDA product code for Genius AI Detection 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.