SHN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Calibration Software For Radiology Displays
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.1940
- Medical specialty
- Radiology
- FDA definition
- The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
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| Record | Firm | Date |
|---|---|---|
| Medical Imaging Calibration Feature (MICF) (K253582) | Apple, Inc. | 2026-04-01 |
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