Cleared Traditional

K253582 - Medical Imaging Calibration Feature (MICF)

K253582 · Apple, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
135d
Days
-
Risk

K253582 is an FDA 510(k) clearance for the Medical Imaging Calibration Feature (MICF).

Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on April 1, 2026 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K253582

510(k) Number K253582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date April 01, 2026
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 107d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

SHN Device Classification - Class ,

Product Code SHN
Device Class -