510(k) · Cleared
ClearedMedical Imaging Calibration Feature (MICF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple, Inc. · SHN Calibration Software For Radiology Displays
Cleared on Apr 1, 2026 after a 135-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 1, 2026
- Review
- 135 days
- Class
- Class I
- Product code
- SHN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Radiologic quality assurance instrument Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SHN devicesSHN Calibration Software For Radiology Displays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHN
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHN
Too few SHN 510(k)s in any year since 2007 to give a median.
Recalls per year · SHN
No recall names SHN since 2007.
Adverse event reports per year · SHN
No MAUDE report names SHN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253582: Medical Imaging Calibration Feature (MICF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253582
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026