GE HealthCare has received U.S. FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-enabled autocontouring software tool for radiation therapy treatment planning.
The software introduces a new MR brain model and an updated CT male pelvis model, according to the company.
The clearance includes a Predetermined Change Control Plan, or PCCP, that establishes a framework for future model updates and enhancements.
GE HealthCare said the PCCP is intended to support expansion across additional anatomical regions and imaging modalities without requiring a separate clearance for each update.
MIM Contour ProtégéAI+ is designed to initiate contouring with minimal user interaction and process CT and MR images automatically.
Results can be exported directly into treatment planning systems or MIM Workflows.
The underlying AI models were developed and validated using multi-institution datasets.
The company said the models demonstrated contour quality comparable to or exceeding traditional approaches across clinical use cases.
The software is part of GE HealthCare’s MIM portfolio within its radiation oncology ecosystem.
GE HealthCare said it will present MIM Contour ProtégéAI+ 2.0 at the American Association of Medical Dosimetrists 51st Annual Meeting, scheduled for June 7-10, 2026, in Orlando, FL.
Companies:GE HealthCare, U.S. Food and Drug Administration
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