K253582
- 510(k) number
- K253582
- Device name
- Medical Imaging Calibration Feature (MICF)
- Applicant
- Apple, Inc. CA · US
- Product code
- SHN — Calibration Software For Radiology Displays
- Decision date
- 2026-04-01
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253582.pdf
Official FDA record: K253582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.