Medical Imaging Calibration Feature (MICF)
Device Facts
| Record ID | K253582 |
|---|---|
| Device Name | Medical Imaging Calibration Feature (MICF) |
| Applicant | Apple, Inc. |
| Product Code | SHN · Radiology |
| Decision Date | Apr 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1940 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
