DeviceClearance

Product code IWB— Radiology

LEKSELL GAMMA KNIFE PERFEXION

Classification name
System, Radiation Therapy, Radionuclide
Device class
Class 2
Regulation
21 CFR 892.5750
Advisory panel
Radiology
Total cleared
48
First cleared
Most recent

Market context for product code IWB

FDA has cleared 48 devices under product code IWB between 1978 and 2025, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code IWB

Recent clearances under product code IWB

Data sourced from openFDA. This site is unofficial and independent of the FDA.