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