FDA product code SHN: Calibration Software For Radiology Displays
SHN is the FDA product code for calibration software for radiology displays. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under SHN, 1 in the last five years. The average 510(k) review took 135 days (median 135); 135 days on average over the last three years.
Definition
The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
Classification
| Field | Value |
|---|---|
| Device name | Calibration Software For Radiology Displays |
| Device class | Class I |
| Regulation | 21 CFR 892.1940 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for SHN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 135 |
Compare with all 510(k) review times · Search every SHN clearance
Top SHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apple, Inc. | 1 | 2026-04-01 |
Most recent SHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253582 | Apple, Inc. | Medical Imaging Calibration Feature (MICF) | 2026-04-01 | 135 |
Recalls for SHN devices
openFDA lists no recalls for product code SHN.
Frequently asked questions
What is FDA product code SHN?
SHN is the FDA product code for calibration software for radiology displays. It is a Class I device, regulated under 21 CFR 892.1940 and reviewed by the Radiology panel.
What device class is SHN?
Class I, regulation 21 CFR 892.1940. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code SHN?
Across 1 cleared submissions the average was 135 days from receipt to decision (median 135).
Which companies have the most SHN clearances?
Apple, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SHN
- Run a recall and safety report across every SHN manufacturer
- Watch product code SHN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times