Cleared Traditional

K242745 - AI-Rad Companion Organs RT

K242745 is the FDA 510(k) clearance for AI-Rad Companion Organs RT by Siemens Healthcare GmbH. It is a Class 2 Radiology device (product code QKB) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K242745 · Siemens Healthcare GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
197d
Days
Class 2
Risk

K242745 is an FDA 510(k) clearance for the AI-Rad Companion Organs RT. Classified as Radiological Image Processing Software For Radiation Therapy (product code QKB), Class II - Special Controls.

Submitted by Siemens Healthcare GmbH (Erlangen, DE). The FDA issued a Cleared decision on March 27, 2025 after a review of 197 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare GmbH devices

Submission Details

510(k) Number K242745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKB Radiological Image Processing Software For Radiation Therapy
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QKB Radiological Image Processing Software For Radiation Therapy

All 45
Devices cleared under the same product code (QKB) and FDA review panel - the closest regulatory comparables to K242745.
ARTAssistant
K250780 · Manteia Technologies Co., Ltd. · Dec 2025
TAIMedImg DeepMets
K250427 · Taiwan Medical Imaging Co., Ltd. · May 2025
MR Contour DL
K242925 · Ge Healthcare · Apr 2025
OncoStudio (OS-01)
K242994 · Oncosoft. Co., Ltd. · Feb 2025
Contour ProtégéAI+
K250035 · Mim Software, Inc. · Feb 2025
AutoContour (Model RADAC V4)
K242729 · Radformation, Inc. · Dec 2024