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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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