DeviceClearance

Product code QKB— Radiology

AI-Rad Companion Organs RT

Classification name
Radiological Image Processing Software For Radiation Therapy
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
49
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QKB under 21 CFR 892.2050, via openFDA

Market context for product code QKB

FDA has cleared 49 devices under product code QKB between 2018 and 2026, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QKB

Recent clearances under product code QKB

Data sourced from openFDA. This site is unofficial and independent of the FDA.