SHN — Calibration Software For Radiology Displays Class I
FDA product code SHN covers "Calibration Software For Radiology Displays", a Class I medical device regulated under 21 CFR 892.1940. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHN
- Device Class
- Class I
- Regulation Number
- 892.1940
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253582 | apple | Medical Imaging Calibration Feature (MICF) | April 1, 2026 |