FDA Product Code LHN: System, Radiation Therapy, Charged-particle, Medical
Leading manufacturers include Varian Medical Systems, Inc., Mevion Medical Systems, Inc. and Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha.
FDA 510(k) Cleared System, Radiation Therapy, Charged-particle, Medical Devices (Product Code LHN)
About Product Code LHN - Regulatory Context
510(k) Submission Activity
91 total 510(k) submissions under product code LHN since 1985, with 91 receiving FDA clearance (average review time: 142 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
Recent submissions under LHN have taken an average of 206 days to reach a decision - up from 138 days historically. Manufacturers should account for longer review timelines in current project planning.
LHN devices are reviewed by the Radiology panel. Browse all Radiology devices →