BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Medical Imaging Calibration Feature (MICF)

    K Number: K253582 · Decision Apr 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    135

    Basic Information

    Device Name
    Medical Imaging Calibration Feature (MICF)
    K Number
    K253582
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1940
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apple, Inc.
    Date Received
    November 17, 2025
    Decision Date
    April 1, 2026
    Product Code
    SHN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SHN Calibration Software For Radiology Displays

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