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., Brainlab AG and Accuray Incorporated.
List of Accelerator, Linear, Medical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Accelerator, Linear, Medical devices (product code IYE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →