IWB · Class II · 21 CFR 892.5750

FDA Product Code IWB: System, Radiation Therapy, Radionuclide

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

Leksell Gamma Knife Icon

Leksell Gamma Knife Perfexion

Leksell Gamma Knife Icon

LEKSELL GAMMA KNIFE PERFEXION

LEKSELL GAMMA KNIFE PERFEXION

EXTEND FRAME SYSTEM, MODEL 1009633

LEKSELL GAMMA KNIFE PERFEXION

LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000

LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001

DISPOSABLE SHADOW TRAY INSERTS

K871215

Mick Radio-Nuclear Instruments, Inc.

Radiology · 11d

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 →

FDA Product Code IWB: System, Radiation Therapy, Radionuclide

FDA 510(k) Cleared System, Radiation Therapy, Radionuclide Devices (Product Code IWB)

About Product Code IWB - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - IWB Product Code

Related FDA 510(k) Regulatory Insights