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510(k) K253582

Medical Imaging Calibration Feature (MICF) by Apple, Inc. — Product Code SHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2026
Date Received
November 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibration Software For Radiology Displays
Device Class
Class I
Regulation Number
892.1940
Review Panel
RA
Submission Type

The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.

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