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FDA-cleared K250064

Dose+ (1.0)

Mvision AI Oy

Authorized purpose: Dose+ 1.0 uses locked machine-learning models to predict a patient-specific three-dimensional dose distribution for men receiving external-beam radiotherapy for localized prostate cancer or prostate cancer with pelvic-node involvement. Qualified users must review its DICOM RT Dose output in a treatment-planning system or compatible viewer.

Modality
Radiotherapy Planning Imaging
Anatomy
Prostate/Pelvis
Decision
2025-09-04
FDA-cleared K241490

Contour+ (MVision AI Segmentation)

MVision AI Oy

Authorized purpose: Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified review and approval.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-10-18