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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears GE HealthCare's MIM Contour ProtégéAI+ 2.0 With a Change Control Plan

The auto-contouring software for radiation therapy planning adds an MR brain model, and its clearance includes a predetermined change control plan for future model updates.

By News DeskJune 4, 20262 min read
An empty radiotherapy room with a white Elekta linear accelerator, a treatment couch and a lit ceiling panel.
A radiation therapy treatment room with a linear accelerator at Gold Coast University Hospital in Australia. Not a GE HealthCare product or the software described in this article. Chris Olszewski, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k)FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • GE HealthCare said on June 4, 2026, that the FDA cleared MIM Contour ProtégéAI+ 2.0, AI software that automatically outlines anatomy on CT and MR images for radiation therapy planning.
  • The clearance includes a predetermined change control plan, which the company said sets a framework for future model updates across more body regions and imaging types.
  • The FDA's 510(k) database lists Contour ProtégéAI+ from MIM Software as K253270, decided March 27, 2026, with a change control plan authorized.

GE HealthCare said on June 4 that the U.S. Food and Drug Administration has given 510(k) clearance to MIM Contour ProtégéAI+ 2.0, artificial intelligence software that automatically outlines organs and other structures on scans used to plan radiation therapy. The clearance includes a predetermined change control plan, which establishes a framework for introducing future model updates and enhancements, according to the company's announcement.

The release does not give a 510(k) number. The FDA's 510(k) database lists a clearance for Contour ProtégéAI+ from MIM Software, K253270, received on September 29, 2025, and found substantially equivalent on March 27, 2026. The entry classifies the product as radiological image processing software for radiation therapy, product code QKB, and marks a predetermined change control plan as authorized.

What changes in version 2.0

Contouring, or drawing the outlines of a tumor and nearby healthy organs on CT or MR images, tells treatment planners where radiation should and should not go. GE HealthCare described manual contouring as one of the most time-intensive steps in radiation therapy planning.

Version 2.0 adds new models, including a magnetic resonance brain model, and an updated CT male pelvis model, the company said. GE HealthCare said the software starts contouring automatically with minimal user interaction and can export results directly into treatment planning systems or its MIM Workflows software.

The company said the underlying models were developed and validated on multi-institution datasets and produced contour quality comparable to, or exceeding, traditional approaches. The release cites a MIM Software white paper for that claim; the FDA database entry does not report performance results.

Why the change control plan matters

GE HealthCare said the plan should help the software's models expand to additional anatomical regions and imaging modalities.

"The FDA clearance of a Predetermined Change Control Plan allows us to iterate more quickly, bringing new models and enhancements to our customers to help enhance the treatment planning experience," said Ben Newton, global head of oncology at GE HealthCare.

The software sits in the MIM portfolio within GE HealthCare's radiation oncology business. The company said it would show the product at the American Association of Medical Dosimetrists annual meeting in Orlando, Fla., on June 7-10. GE HealthCare did not disclose pricing or a release date in the announcement.

Sources

  1. GE HealthCare receives FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, advancing AI-enabled radiation therapy planning with expanded clinical capabilities, GE HealthCare, June 4, 2026
  2. 510(k) Premarket Notification K253270: Contour ProtégéAI+, U.S. Food and Drug Administration, March 27, 2026