FDA product code IYQ: Phantom, Flood Source, Nuclear
IYQ is the FDA product code for phantom, flood source, nuclear. It is a Class I device, regulated under 21 CFR 892.1380 and reviewed by the Radiology panel. Devices under IYQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Phantom, Flood Source, Nuclear |
| Device class | Class I |
| Regulation | 21 CFR 892.1380 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for IYQ devices
openFDA lists no recalls for product code IYQ.
Frequently asked questions
What is FDA product code IYQ?
IYQ is the FDA product code for phantom, flood source, nuclear. It is a Class I device, regulated under 21 CFR 892.1380 and reviewed by the Radiology panel.
What device class is IYQ?
Class I, regulation 21 CFR 892.1380. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IYQ
- Run a recall and safety report across every IYQ manufacturer
- Watch product code IYQ 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.