FDA product code IYL: Collimator, Dermatological, Therapeutic X-Ray
IYL is the FDA product code for collimator, dermatological, therapeutic x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IYL. The average 510(k) review took 107 days (median 107).
Classification
| Field | Value |
|---|---|
| Device name | Collimator, Dermatological, Therapeutic X-Ray |
| Device class | Class II |
| Regulation | 21 CFR 892.5900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IYL clearance
Top IYL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 1 | 1984-07-18 |
Most recent IYL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841359 | Treace Medical, Inc. | FENESTRA HOOK | 1984-07-18 | 107 |
Recalls for IYL devices
openFDA lists no recalls for product code IYL.
Frequently asked questions
What is FDA product code IYL?
IYL is the FDA product code for collimator, dermatological, therapeutic x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel.
What device class is IYL?
Class II, regulation 21 CFR 892.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code IYL?
Across 1 cleared submissions the average was 107 days from receipt to decision (median 107).
Which companies have the most IYL clearances?
Treace Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IYL
- Run a recall and safety report across every IYL manufacturer
- Watch product code IYL 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