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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibration Software For Radiology Displays
510(k) Number K253582
Device Name Medical Imaging Calibration Feature (MICF)
Applicant
Apple, Inc.
1 Apple Park Way
Cupertino,  CA  95014
Applicant Contact Lynda Ikejimba
Correspondent
Apple, Inc.
1 Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Lynda Ikejimba
Regulation Number892.1940
Classification Product Code
SHN  
Date Received11/17/2025
Decision Date 04/01/2026
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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