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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 K230096
Device Name Genius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.
250 Campus Drive
Marlborough,  MA  01730
Applicant Contact Deborah Thomas
Hologic, Inc.
250 Campus Drive
Marlborough,  MA  01730
Correspondent Contact Deborah Thomas
Regulation Number892.2090
Classification Product Code
Date Received01/13/2023
Decision Date 05/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No