Devices · Elekta Solutions AB

Advanced Algorithms for Treatment Management Applications (AATMA)

Elekta Solutions AB is listed for Advanced Algorithms for Treatment Management Applications (AATMA) (K212218). The FDA list gives October 25, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QKB as “Radiological Image Processing Software For Radiation Therapy”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212218

Official FDA database record

Date of final decision

October 25, 2021

Company on the FDA list

Elekta Solutions AB

Lead panel

Radiology

Primary product code

QKB

openFDA device name for the code

Radiological Image Processing Software For Radiation Therapy

Device class

2

Regulation number

892.2050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary