Cleared Traditional

AVIEW RT ACS

K220408 · Coreline Soft Co., Ltd. · Radiology
Nov 2022
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K220408 is an FDA 510(k) clearance for the AVIEW RT ACS, a Radiological Image Processing Software For Radiation Therapy (Class II — Special Controls, product code QKB), submitted by Coreline Soft Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 10, 2022, 269 days after receiving the submission on February 14, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K220408 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2022
Decision Date November 10, 2022
Days to Decision 269 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.