Cleared Traditional

AI-Rad Companion Organs RT

K242745 · Siemens Healthcare GmbH · Radiology

Mar 2025

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K242745 is an FDA 510(k) clearance for the AI-Rad Companion Organs RT, a Radiological Image Processing Software For Radiation Therapy (Class II — Special Controls, product code QKB), submitted by Siemens Healthcare GmbH (Erlangen, DE). The FDA issued a Cleared decision on March 27, 2025, 197 days after receiving the submission on September 11, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K242745 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2024
Decision Date	March 27, 2025
Days to Decision	197 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.