46 devices · 30 companies · 2018 to 2026

Product code QKB: Radiological Image Processing Software For Radiation Therapy

46 devices under product code QKB, 2018 to 2026, from 30 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (44 of 46 here), the regulation, and MAUDE report counts by product code.

Radiological Image Processing Software For Radiation Therapy. 21 CFR 892.2050, Class II. To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved 2026-10-29 from FDA public records.