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510(k) K253582

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

K253582 is an FDA 510(k) premarket notification submitted by Apple, Inc. for the device "Medical Imaging Calibration Feature (MICF)". The FDA issued a decision of Substantially Equivalent on April 1, 2026. The device falls under product code SHN (Calibration Software For Radiology Displays), a Class I device regulated under 21 CFR 892.1940. Apple, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Apple, Inc.

  • K250507 — Hypertension Notification Feature (HTNF) (September 11, 2025)
  • K250143 — Digital Prism Correction Feature (DPCF) (June 23, 2025)
  • K242058 — Digital Prism Correction Feature (DPCF) (October 21, 2024)
  • K240929 — Sleep Apnea Notification Feature (SANF) (September 13, 2024)
  • DEN230081 — Hearing Aid Feature (HAF) (September 12, 2024)
  • K231173 — Irregular Rhythm Notification Feature (IRNF) (July 21, 2023)
  • K213971 — Atrial Fibrillation History Feature (June 3, 2022)
  • K212516 — IRNF App (October 22, 2021)
  • K201525 — ECG App (October 8, 2020)
  • DEN180042 — Irregular Rhythm Notification Feature (September 11, 2018)

FDA data resources