FDA Product Code QKB: Radiological Image Processing Software For Radiation Therapy
Accurate dose delivery in radiation therapy depends on precise delineation of target structures and organs at risk. FDA product code QKB covers radiological image processing software for radiation treatment planning.
These systems use semi-automatic or fully automated algorithms to segment tumors and critical structures on CT, MRI, or PET images, producing contours that define the treatment target and dose constraints for treatment planning. AI-based auto-segmentation tools have dramatically reduced the time required for this step.
QKB devices are Class II medical devices, regulated under 21 CFR 892.2050 and reviewed by the FDA Radiology panel.
Leading manufacturers include Mim Software, Inc., Radformation, Inc. and Manteia Technologies Co., Ltd..
FDA 510(k) Cleared Radiological Image Processing Software For Radiation Therapy Devices (Product Code QKB)
About Product Code QKB - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code QKB since 2018, with 46 receiving FDA clearance (average review time: 158 days).
Submission volume has remained relatively stable over the observed period, with 15 submissions in the last 24 months.
FDA Review Time
FDA review times for QKB submissions have been consistent, averaging 169 days recently vs 153 days historically.
QKB devices are reviewed by the Radiology panel. Browse all Radiology devices →