Apple, Inc. · Class I · Cleared Apr 1, 2026
| K-number | K253582 |
| Device name | Medical Imaging Calibration Feature (MICF) |
| Applicant | Apple, Inc. |
| Product code | SHN |
| Device class | Class I |
| Decision date | Apr 1, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1940 |
The Medical Imaging Calibration Feature (MICF) is a software-only device that calibrates compatible Apple desktop displays to enable their use for primary diagnostic radiology and medical image review. It is intended for use by trained medical practitioners authorized by their facility's quality assurance program.
The MICF is a software-only device using compatible off-the-shelf (OTS) Apple displays with a general-purpose macOS host computer and external colorimeter, whereas the predicate device uses hardware and/or software with dedicated medical displays. The MICF supports color imaging, minimum 27-inch displays at 5120×2880 resolution, and frame rates of 47–120 Hz.
IEC 62563-1 and IEC 62563-2 (medical image display systems evaluation and acceptance tests), AAPM TG-18 and TG-270 (quality control parameters for medical displays), DICOM standards, IEC 82304-1 (health software safety), and IEC 62304 (medical device software life cycle).
Both devices share the same intended use as radiologic quality assurance instruments for display calibration to enable primary diagnostic radiology. Technological differences (software-only vs. hardware-inclusive, OTS vs. medical displays) do not raise different safety or effectiveness questions because calibration software is well-characterized with known low risk. Software verification, hardware verification, and bench validation testing per international standards demonstrate the MICF meets technical requirements equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov