IWL · Class II · 21 CFR 892.5300

FDA Product Code IWL: System, Radiation Therapy, Neutron, Medical

Leading manufacturers include The Cyclotron Corp., Northern Illinois Univ. Outreach and Medcyc. Corp..

4
Total
4
Cleared
57d
Avg days
1981
Since

FDA 510(k) Cleared System, Radiation Therapy, Neutron, Medical Devices (Product Code IWL)

4 devices
1–4 of 4
Cleared Jan 31, 2007
NEUTRON THERAPY SYSTEM
K063691
Northern Illinois Univ. Outreach
Radiology · 50d
Cleared Oct 15, 1985
MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS
K852804
Medcyc. Corp.
Radiology · 104d
Cleared Oct 02, 1981
ISOCENTRIC NEUTRON THERAPY SYSTEMS
K812337
The Cyclotron Corp.
Radiology · 45d
Cleared Jul 23, 1981
MODEL 4100 14 MEV NEUTRON GEN. THERAPY
K811778
The Cyclotron Corp.
Radiology · 30d

About Product Code IWL - Regulatory Context