FDA Product Code IXI: Block, Beam-shaping, Radiation Therapy
Leading manufacturers include Ricoh 3D For Healthcare, LLC.
FDA 510(k) Cleared Block, Beam-shaping, Radiation Therapy Devices (Product Code IXI)
About Product Code IXI - Regulatory Context
510(k) Submission Activity
51 total 510(k) submissions under product code IXI since 1979, with 51 receiving FDA clearance (average review time: 108 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under IXI have taken an average of 199 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
IXI devices are reviewed by the Radiology panel. Browse all Radiology devices →