DOSIsoft Receives FDA 510(k) Clearance for ThinkQA 3.0, a Unified Patient-Specific QA Platform for Offline and Online Adaptive Radiotherapy

Coral Gables, FL, USA | Monday, June 22, 2026

DOSIsoft, leading provider of patient-specific imaging and dosimetry software solutions for radiation oncology and nuclear medicine, is pleased to share that it has obtained 510(k) clearance from the US Food and Drug Administration (FDA) on June 12th, 2026, for the commercialization of ThinkQA 3.0.

As radiation therapy advances toward modern, time-constrained online Adaptive Radiation Therapy (ART), Patient Specific Quality Assurance (PSQA) processes must become faster, more reliable, and more integrated into clinical workflows. ThinkQA 3.0 addresses these challenges by combining speed, accuracy & simplicity into a unified web-based platform designed to support online ART workflow, for both CT-Linacs and MR-Linacs. 


ThinkQA 3.0: Clinically Proven Design Innovation to Streamline Patient QA Experience

  • Automated PSQA: GPU-powered 3D Collapsed Cone Convolution (CCC) algorithm delivering QA results in just 1-2 minutes
  • Integrated workflow: seamless integration into Elekta ONE without adding time to the routine QA process
  • Centralized QA Management: all pre- & post- treatment PSQA tasks managed within a single and connected platform
  • Simplified QA user experience: Enhanced usability and modern web-based access to improve efficiency and ease of use

ThinkQA 3.0: Delivering End-to-end QA Compabilities for Adaptive Radiation Therapy 

Tailored to meet the evolving requirements of adaptive radiotherapy, ThinkQA 3.0 represents a significant technological advancement, fully supporting both online and offline adaptive workflows. It is powered by a unique, fast, and optimized Collapsed Cone Convolution (CCC) calculation engine validated against Monte Carlo simulations. By leveraging the same calculation engine across all patient-specific QA verifications, ThinkQA 3.0 delivers consistent 3D dose calculations and 2D dose image comparisons while minimizing uncertainties and biases associated with multiple calculation engines.

  • Secondary dose check: Independent full 3D dose calculation, automatically handling adapt-to-position and adapt-to-shape plans
  • Logfile analysis: Automated pre-treatment and in vivo treatment verifications, based on machine delivery logs, and computed into 3D dose distributions
  • Pretreatment check: EPID-based phantom-less QA providing instant gamma-based comparison results
  • In vivo dosimetry check: EPID-based transit dosimetry QA for dose deviation detection during patient treatment

ThinkQA 3.0: Designed for Broad Compatiblity and Seamless Implementation

Designed as a multi-vendor solution, ThinkQA 3.0 supports a wide range of modern linear accelerators, in the mixed environment including advanced CT-Linac and MR-Linac. Configured using ready-to-use beam templates and machine models, it simplifies the overall commissioning, to reduce implementation workload, and support compliance with clinical quality and regulatory requirements.

For Elekta Unity MR-Linac users, the advanced CCC calculation engine accurately models both cryostat transmission and magnetic field effects on dose distribution, ensuring reliable and clinically relevant verification results in this highly specialized treatment environment.

“The FDA 510(k) clearance of ThinkQA 3.0 marks an important milestone for DOSIsoft. We are delighted that U.S. radiation oncology departments can now benefit from a modern, web-based and vendor-agnostic QA platform that unifies secondary dose calculation, EPID-based verification, logfile analysis, and in vivo dosimetry within a single environment. ThinkQA 3.0 helps improve efficiency, simplify adaptive radiotherapy workflows, and support consistent, high-quality patient care.” said Jean-Elie Kafrouni, CEO of DOSIsoft, Inc.

As part of the Elekta ONE solution, ThinkQA 3 live demonstrations will be available at the Elekta booth #1131 during AAPM 2026.


About DOSIsoft

Founded in 2002, DOSIsoft is a market leader in dosimetry software for radiation oncology and nuclear medicine, dedicated to improving cancer treatment quality and patient safety. With more than 1,000 installations across 800+ hospital centers in 80 countries, DOSIsoft provides advanced solutions for radiation therapy quality assurance, theranostics, and personalized dosimetry. A spin-off from Gustave Roussy and Institut Curie, DOSIsoft continues to innovate through close collaboration with leading cancer centers worldwide.  www.dosisoft.com

About ThinkQA

ThinkQA 3 is FDA 510(k) cleared. The product may not be available in all markets. Please contact your local sales representative for more information.

ThinkQA 3.0 is distributed exclusively by Elekta www.elekta.com

Press contact        Xiaolu CHEN | xiaolu.chen@dosisoft.com

DOSIsoft                 +33 (0)1 41 24 26 26 | 45/47, Avenue Carnot, 94230 Cachan, France

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