FDA product code IWK: Cyclotron, Medical
IWK is the FDA product code for cyclotron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. Devices under IWK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cyclotron, Medical |
| Device class | Class II |
| Regulation | 21 CFR 892.5050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for IWK devices
openFDA lists no recalls for product code IWK.
Frequently asked questions
What is FDA product code IWK?
IWK is the FDA product code for cyclotron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is IWK?
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 IWK
- Run a recall and safety report across every IWK manufacturer
- Watch product code IWK 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times