FDA product code IWM: Synchrotron, Medical
IWM is the FDA product code for synchrotron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IWM. The average 510(k) review took 248 days (median 248).
Classification
| Field | Value |
|---|---|
| Device name | Synchrotron, Medical |
| Device class | Class II |
| Regulation | 21 CFR 892.5050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every IWM clearance
Top IWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Loma Linda University Medical Center | 1 | 1988-02-22 |
Most recent IWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872369 | Loma Linda University Medical Center | LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM | 1988-02-22 | 248 |
Recalls for IWM devices
openFDA lists no recalls for product code IWM.
Frequently asked questions
What is FDA product code IWM?
IWM is the FDA product code for synchrotron, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is IWM?
Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code IWM?
Across 1 cleared submissions the average was 248 days from receipt to decision (median 248).
Which companies have the most IWM clearances?
Loma Linda University Medical Center (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWM
- Run a recall and safety report across every IWM manufacturer
- Watch product code IWM 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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