Cleared Traditional

AutoContour Model RADAC V2

K220598 · Radformation, Inc. · Radiology
Aug 2022
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K220598 is an FDA 510(k) clearance for the AutoContour Model RADAC V2, a Radiological Image Processing Software For Radiation Therapy (Class II — Special Controls, product code QKB), submitted by Radformation, Inc. (New York, US). The FDA issued a Cleared decision on August 24, 2022, 175 days after receiving the submission on March 2, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K220598 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2022
Decision Date August 24, 2022
Days to Decision 175 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.