FDA product code IYG: Betatron, Medical
IYG is the FDA product code for betatron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. Devices under IYG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Betatron, Medical |
| Device class | Class II |
| Regulation | 21 CFR 892.5050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for IYG devices
openFDA lists no recalls for product code IYG.
Frequently asked questions
What is FDA product code IYG?
IYG is the FDA product code for betatron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is IYG?
Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code IYG
- Run a recall and safety report across every IYG manufacturer
- Watch product code IYG 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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