FDA product code IYJ: Collimator, Low Voltage, Therapeutic X-Ray
IYJ is the FDA product code for collimator, low voltage, therapeutic x-ray. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel. Devices under IYJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Collimator, Low Voltage, 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 |
Recalls for IYJ devices
openFDA lists no recalls for product code IYJ.
Frequently asked questions
What is FDA product code IYJ?
IYJ is the FDA product code for collimator, low voltage, 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 IYJ?
Class II, regulation 21 CFR 892.5900. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code IYJ
- Run a recall and safety report across every IYJ manufacturer
- Watch product code IYJ 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.
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