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FDA 510(k)

Medical Imaging Calibration Feature (MICF)

K-Number: K253582 · 2026-04-01

ApplicantApple, Inc.
Decision Date2026-04-01
Product CodeSHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medical Imaging Calibration Feature (MICF) is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K253582. The device is classified under product code SHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Imaging Calibration Feature (MICF)?

Medical Imaging Calibration Feature (MICF) is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Apple, Inc.. The 510(k) number is K253582.

When did Medical Imaging Calibration Feature (MICF) receive FDA 510(k) clearance?

Medical Imaging Calibration Feature (MICF) received FDA 510(k) clearance on 2026-04-01, under 510(k) number K253582.

Who is the listed applicant for Medical Imaging Calibration Feature (MICF)?

The FDA 510(k) record lists Apple, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Imaging Calibration Feature (MICF)?

The FDA product code for Medical Imaging Calibration Feature (MICF) is SHN.

Other records listing Apple, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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