Device Atlas

Medical Imaging Calibration Feature (MICF)

Q: What is the product code of K253582?

The FDA product code is SHN – Calibration Software For Radiology Displays, a Class I (low risk) device regulated under 21 CFR 892.1940.

FDA 510(k) K253582 · Apple, Inc.

Substantially Equivalent

510(k) numberK253582

Submission

Device name: Medical Imaging Calibration Feature (MICF)
Applicant: Apple, Inc.
Cupertino, CA, US
Received: November 17, 2025
Decision date: April 1, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SHN – Calibration Software For Radiology Displays
Device class: Class I (low risk)
Regulation: 21 CFR 892.1940
Specialty: Radiology

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

More from Apple, Inc.

510(k)	Device	Decision
K250507	Hypertension Notification Feature (HTNF)SFR · Traditional	09/11/2025SE
K250143	Digital Prism Correction Feature (DPCF)SCW · Traditional	06/23/2025SE
K242058	Digital Prism Correction Feature (DPCF)SCW · Traditional	10/21/2024SE
K240929	Sleep Apnea Notification Feature (SANF)QZW · Traditional	09/13/2024SE
K231173	Irregular Rhythm Notification Feature (IRNF)QDB · Traditional	07/21/2023SE
K213971	Atrial Fibrillation History FeatureQDB · Traditional	06/03/2022SE
K212516	IRNF AppQDB · Traditional	10/22/2021SE
K201525	ECG AppQDA · Traditional	10/08/2020SE

Questions and answers

When was Medical Imaging Calibration Feature (MICF) cleared by the FDA?

Medical Imaging Calibration Feature (MICF) (K253582) received a 510(k) decision of Substantially Equivalent on April 1, 2026, 135 days after the submission was received.

What is the product code of K253582?

The FDA product code is SHN – Calibration Software For Radiology Displays, a Class I (low risk) device regulated under 21 CFR 892.1940.