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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K254090
Device Name I-View®
Applicant
Hologic, Inc.
600 Technology Dr.
Newark,  DE  19702
Applicant Contact Manuela Restrepo Parra
Correspondent
Hologic, Inc.
600 Technology Dr.
Newark,  DE  19702
Correspondent Contact Manuela Restrepo Parra
Regulation Number892.1715
Classification Product Code
MUE  
Date Received12/19/2025
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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