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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 a medical device manufactured by Apple, Inc.. It received FDA 510(k) clearance on 2026-04-01 under approval 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. It is manufactured by Apple, Inc.. The 510(k) number is K253582.

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

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

What company makes Medical Imaging Calibration Feature (MICF)?

Medical Imaging Calibration Feature (MICF) is manufactured by Apple, Inc..

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

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

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026)

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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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