IWB

System, Radiation Therapy, Radionuclide

Product code
IWB
Device name
System, Radiation Therapy, Radionuclide
Device class
Class 2
21 CFR
21 CFR 892.5750
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
48 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-07-02.

NumberDecision dateApplicantDevice nameSummary
K2503912025-07-02Elekta Solutions ABLeksell Gamma Knife® (Elekta Esprit); Leksell Gamma …PDF
K2328542024-02-08Elekta Solutions ABLeksell GammaPlan (LGP)PDF

2 summaries are archived here for direct download.

Official FDA classification page: IWB
Classification and pathway per current FDA publications. Data from openFDA (CC0).