QKB

Radiological Image Processing Software For Radiation Therapy

Product code

QKB

Device name

Radiological Image Processing Software For Radiation Therapy

Device class

Class 2

21 CFR

21 CFR 892.2050

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

23

Summaries archived here

20 (direct download)

510(k) clearances (all years, FDA)

49 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (23)

Last three years. Most recent: 2026-08-14.

20 summaries are archived here for direct download.