FDA Product Code MUJ: System, Planning, Radiation Therapy Treatment
Precision in radiation therapy begins before the first beam is delivered. FDA product code MUJ covers radiation therapy treatment planning systems.
These software platforms import patient imaging data, define target volumes and critical structures, and calculate optimized dose distributions for external beam and brachytherapy treatments. They are the computational backbone of modern radiotherapy and work in conjunction with linear accelerators and brachytherapy systems.
MUJ 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., RaySearch Laboratories AB (PUBL) and Therapanacea Sas.
FDA 510(k) Cleared System, Planning, Radiation Therapy Treatment Devices (Product Code MUJ)
About Product Code MUJ - Regulatory Context
510(k) Submission Activity
252 total 510(k) submissions under product code MUJ since 1995, with 252 receiving FDA clearance (average review time: 116 days).
Submission volume has increased in recent years - 20 submissions in the last 24 months compared to 16 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MUJ have taken an average of 172 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.
MUJ devices are reviewed by the Radiology panel. Browse all Radiology devices →