QKB · Class II · 21 CFR 892.2050

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 Ever Fortune.Ai, Co., Ltd..

46
Total
46
Cleared
158d
Avg days
2018
Since
46 devices
25–46 of 46
Cleared Feb 03, 2022
Contour ProtégéAI
K213976
Mim Software, Inc.
Radiology · 45d
Cleared Oct 20, 2021
Contour ProtegeAI
K210632
Mim Software, Inc.
Radiology · 231d