510(k) K253582 ยท SHN Calibration Software For Radiology Displays
Medical Imaging Calibration Feature (MICF)
| Applicant | Apple, Inc., Cupertino CA, US |
| Decision | Substantially Equivalent, Apr 1, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253582
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.