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 Elekta Solutions AB.
FDA 510(k) Cleared Accelerator, Linear, Medical Devices (Product Code IYE)
About Product Code IYE - Regulatory Context
510(k) Submission Activity
731 total 510(k) submissions under product code IYE since 1977, with 731 receiving FDA clearance (average review time: 130 days).
Submission volume has declined in recent years - 21 submissions in the last 24 months compared to 31 in the prior period.
FDA Review Time
Recent submissions under IYE have taken an average of 159 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
IYE devices are reviewed by the Radiology panel. Browse all Radiology devices →