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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K243341
Device Name Genius AI Detection 2.0
Applicant
Hologic, Inc.
600 Technology Dr.
Newark,  DE  19702
Applicant Contact Julia Vaillancourt
Correspondent
Hologic, Inc.
600 Technology Dr.
Newark,  DE  19702
Correspondent Contact Julia Vaillancourt
Classification Product Code
QDQ  
Date Received10/25/2024
Decision Date 07/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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