FDA product code IWL: System, Radiation Therapy, Neutron, Medical
IWL is the FDA product code for system, radiation therapy, neutron, medical. It is a Class II device, regulated under 21 CFR 892.5300 and reviewed by the Radiology panel. FDA has cleared 4 510(k) submissions under IWL, from 3 different applicants. The average 510(k) review took 57 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | System, Radiation Therapy, Neutron, Medical |
| Device class | Class II |
| Regulation | 21 CFR 892.5300 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every IWL clearance
Top IWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Cyclotron Corp. | 2 | 1981-10-02 |
| Northern Illinois Univ. Outreach | 1 | 2007-01-31 |
| Medcyc. Corp. | 1 | 1985-10-15 |
Most recent IWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063691 | Northern Illinois Univ. Outreach | NEUTRON THERAPY SYSTEM | 2007-01-31 | 50 |
| K852804 | Medcyc. Corp. | MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS | 1985-10-15 | 104 |
| K812337 | The Cyclotron Corp. | ISOCENTRIC NEUTRON THERAPY SYSTEMS | 1981-10-02 | 45 |
| K811778 | The Cyclotron Corp. | MODEL 4100 14 MEV NEUTRON GEN. THERAPY | 1981-07-23 | 30 |
Recalls for IWL devices
openFDA lists no recalls for product code IWL.
Frequently asked questions
What is FDA product code IWL?
IWL is the FDA product code for system, radiation therapy, neutron, medical. It is a Class II device, regulated under 21 CFR 892.5300 and reviewed by the Radiology panel.
What device class is IWL?
Class II, regulation 21 CFR 892.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code IWL?
Across 4 cleared submissions the average was 57 days from receipt to decision (median 48).
Which companies have the most IWL clearances?
The Cyclotron Corp. (2); Northern Illinois Univ. Outreach (1); Medcyc. Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWL
- Run a recall and safety report across every IWL manufacturer
- Watch product code IWL 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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