SHN
- Product code
- SHN
- Device name
- Calibration Software For Radiology Displays
- Device class
- Class 1
- 21 CFR
- 21 CFR 892.1940
- Medical specialty
- Radiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
FDA classification definition
The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253582 | 2026-04-01 | Apple, Inc. | Medical Imaging Calibration Feature (MICF) |
Official FDA classification page: SHN
Classification and pathway per current FDA publications. Data from openFDA (CC0).