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