FDA Product Code IWB: System, Radiation Therapy, Radionuclide
Leading manufacturers include Elekta Solutions AB.
48
Total
48
Cleared
126d
Avg days
1978
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
140d avg (recent)
FDA 510(k) Cleared System, Radiation Therapy, Radionuclide Devices (Product Code IWB)
48 devices
Cleared
Jul 02, 2025
Leksell Gamma Knife® (Elekta Esprit)
Elekta Solutions AB
Radiology
140d
Cleared
Feb 08, 2024
Leksell GammaPlan (LGP)
Elekta Solutions AB
Radiology
146d
About Product Code IWB - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code IWB since 1978, with 48 receiving FDA clearance (average review time: 126 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
FDA review times for IWB submissions have been consistent, averaging 140 days recently vs 126 days historically.
IWB devices are reviewed by the Radiology panel. Browse all Radiology devices →