Calibration Software For Radiology Displays
FDA product code SHN · Class I (low risk) · 21 CFR 892.1940 · Radiology
The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF)SHN · Traditional | Apple, Inc. | 04/01/2026SE |