Cleared Traditional

Advanced Algorithms for Treatment Management Applications (AATMA)

K212218 · Elekta Solutions AB · Radiology
Oct 2021
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K212218 is an FDA 510(k) clearance for the Advanced Algorithms for Treatment Management Applications (AATMA), a Radiological Image Processing Software For Radiation Therapy (Class II — Special Controls, product code QKB), submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on October 25, 2021, 101 days after receiving the submission on July 16, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K212218 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2021
Decision Date October 25, 2021
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QKB — Radiological Image Processing Software For Radiation Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
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.