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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 K201019
Device Name Genius AI Detection
Applicant
Hologic, Inc.
250 Campus Drive
Marlborough,  MA  01752
Applicant Contact Deborah Thomas
Correspondent
Hologic, Inc.
250 Campus Drive
Marlborough,  MA  01752
Correspondent Contact Deborah Thomas
Classification Product Code
QDQ  
Date Received04/17/2020
Decision Date 11/18/2020
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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