FDA Product Code IYE: Accelerator, Linear, Medical

Medical linear accelerators are the cornerstone of modern radiation oncology. FDA product code IYE covers medical linear accelerators used for external beam radiation therapy.

These systems generate high-energy X-ray or electron beams to destroy cancer cells while minimizing damage to surrounding healthy tissue. Advanced systems incorporate image guidance, intensity modulation, and stereotactic radiosurgery capabilities for highly precise dose delivery.

IYE devices are Class II medical devices, regulated under 21 CFR 892.5050 and reviewed by the FDA Radiology panel.

Leading manufacturers include Varian Medical Systems, Inc., Siemens Medical Solutions USA, Inc. and Brainlab AG.