Radiological Image Processing Software for Radiation Therapy

What Is This Device?

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.

How Is QKB Classified?

Radiological Image Processing Software For Radiation Therapy is FDA product code QKB, Class 2, 21 CFR 892.2050.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 6 clearances under this code; the FDA took a median of 248 days from receipt to decision on them.