FDA product code IWH: Source, Teletherapy, Radionuclide
IWH is the FDA product code for source, teletherapy, radionuclide. It is a Class I device, regulated under 21 CFR 892.5740 and reviewed by the Radiology panel. Devices under IWH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Source, Teletherapy, Radionuclide |
| Device class | Class I |
| Regulation | 21 CFR 892.5740 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for IWH devices
openFDA lists no recalls for product code IWH.
Frequently asked questions
What is FDA product code IWH?
IWH is the FDA product code for source, teletherapy, radionuclide. It is a Class I device, regulated under 21 CFR 892.5740 and reviewed by the Radiology panel.
What device class is IWH?
Class I, regulation 21 CFR 892.5740. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IWH
- Run a recall and safety report across every IWH manufacturer
- Watch product code IWH 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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