# K253582: Medical Imaging Calibration Feature (MICF)

- Pathway: 510(k) (Traditional)
- Applicant: Apple, Inc.
- Decided: Apr 1, 2026 after 135 days
- Product code: SHN (Calibration Software For Radiology Displays)
- Device class: 1
- Regulation: 21 CFR 892.1940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Radiologic quality assurance instrument: named in the summary without a submission number

## Indications for use
The Medical Imaging Calibration Feature (MICF) is a software-only medical device intended to calibrate compatible general purpose off-the-shelf (OTS) desktop displays. The MICF is intended to be used by trained medical practitioners for the purpose of enabling primary diagnostic interpretation and medical image review. The MICF is intended to be used with specific macOS host and Apple display platforms. The MICF is not compatible with head-mounted displays, laptops, tablets, phones, or other portable displays that are not desktop displays. The device is not intended for mammography.

Source page: https://510kreport.com/device/K253582
Methodology: https://510kreport.com/methodology