Marie

The Marie Imaging System is a CT scanner combined with a patient positioning system designed to acquire CT images and precisely position patients in an upright seated position for external beam radiation therapy treatment planning and delivery. It enables image-guided radiation therapy and treatment simulation while maintaining patients in upright posture rather than conventional supine positioning.

Marie has an 84 cm bore diameter, acquires axial and multi-slice helical scans with 0.625-5.0 mm slice thickness, achieves 4.0 lp/cm at 50% MTF image resolution, and includes a chair-based patient support with 6 degrees of freedom motion controlled by servo motors. The predicate P-ARTIS has an 85 cm bore, 2.0-8.0 mm slice thickness, 4.3 lp/cm resolution, and a patient table couch support. Both systems support 15-degree pitch range and full 360-degree rotation with comparable imaging angle and gantry scan plane characteristics.

ISO 14971:2019 (risk management), IEC 60601-1 Edition 3.2 (general safety), IEC 60601-2-44 Edition 3.2 (CT equipment safety), IEC 60601-2-68 Edition 1.0 (image-guided radiotherapy equipment), IEC 60601-1-2 Edition 4.1 (electromagnetic disturbances), IEC 62304:2016 (software life-cycle), IEC 60601-1-6:2020 (usability), and ANSI AAMI IEC 62366-1:2020 (usability engineering). Performance tested against AAPM Report 233 (CT system evaluation), AAPM TG-179 (image-guided RT QA), and AAPM TG-66 (CT simulator QA).

Marie is substantially equivalent because it performs the same intended use—CT imaging and patient positioning for external beam radiation therapy—as the predicate P-ARTIS using substantially similar CT imaging technology (helical scanning, 2D/3D reconstruction, comparable resolution and bore diameter). Although Marie uses chair-based positioning versus a table couch and has a lower maximum patient load (150 kg vs 375 kg), these differences do not raise new safety or efficacy concerns because both systems achieve the same clinical functions through equivalent imaging and positioning mechanisms, and all performance specifications meet or exceed established AAPM consensus standards for CT simulators and image-guided radiotherapy.