Cleared Traditional

MR Contour DL

K242925 · Ge Healthcare · Radiology

Apr 2025

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K242925 is an FDA 510(k) clearance for the MR Contour DL, a Radiological Image Processing Software For Radiation Therapy (Class II — Special Controls, product code QKB), submitted by Ge Healthcare (Chicago, US). The FDA issued a Cleared decision on April 1, 2025, 189 days after receiving the submission on September 24, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K242925 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2024
Decision Date	April 01, 2025
Days to Decision	189 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.