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FDA-cleared K212915

MVision AI Segmentation

MVision AI

Authorized purpose: MVision AI Segmentation automatically generates initial contours from CT images for radiotherapy planning; the contours are transferred for professional visualization, review, modification, and approval, and the labeled software is not intended for lesion or tumor detection or real-time adaptive planning.

Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck, brain, breast, lung and abdomen, male pelvis, and female pelvis structures
Decision
2022-05-03