IWB · Class II · 21 CFR 892.5750

FDA Product Code IWB: System, Radiation Therapy, Radionuclide

Leading manufacturers include Akesis, Inc., Elekta Solutions AB and Elekta Instrument AB.

Total

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

1–24 of 48

Cleared Jul 02, 2025

Leksell Gamma Knife® (Elekta Esprit)

Leksell GammaPlan (LGP)

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)

Our United Corporation

Xcision Medical Systems, LLC

Radiology · 30d

Cleared Mar 30, 2018

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

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 510(k) Review Time - IWB Product Code

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 →

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Jul 02, 2025

Product Code Info

Code	IWB
Device class	Class II
CFR	21 CFR 892.5750
Panel	Radiology

Verify on FDA.gov

View IWB classification on FDA.gov →