FDA product code IWD: Device, Beam Limiting, Teletherapy, Radionuclide
IWD is the FDA product code for device, beam limiting, teletherapy, radionuclide. It is a Class II device, regulated under 21 CFR 892.5750 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IWD. The average 510(k) review took 191 days (median 191).
Classification
| Field | Value |
|---|---|
| Device name | Device, Beam Limiting, Teletherapy, Radionuclide |
| Device class | Class II |
| Regulation | 21 CFR 892.5750 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IWD clearance
Top IWD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Theratronics, Inc. | 1 | 1997-05-28 |
Most recent IWD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964607 | Theratronics, Inc. | THERATON 1000E | 1997-05-28 | 191 |
Recalls for IWD devices
openFDA lists no recalls for product code IWD.
Frequently asked questions
What is FDA product code IWD?
IWD is the FDA product code for device, beam limiting, teletherapy, radionuclide. It is a Class II device, regulated under 21 CFR 892.5750 and reviewed by the Radiology panel.
What device class is IWD?
Class II, regulation 21 CFR 892.5750. Typical premarket route: 510(k).
How long does a 510(k) take for product code IWD?
Across 1 cleared submissions the average was 191 days from receipt to decision (median 191).
Which companies have the most IWD clearances?
Theratronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWD
- Run a recall and safety report across every IWD manufacturer
- Watch product code IWD 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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