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Contour+ (MVision AI Segmentation)

Mvision AI Oy · Model 1.2 · UDI-DI 06429830064206

QKB Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
21
Facilities

Description

Contour+ (MVision AI Segmentation) provides a software interface to image analysis algorithms to be used in clinical workflows including, but not limited to, radiation therapy treatment planning workflows. The system includes processing tools for automatically contouring of imaging data of supported modalities CT and MRI using machine learning based algorithms. The produced segmentation templates for regions of interest are intended to be transferred to appropriate image visualization systems to be used as a template for a medical professional to visualize, modify and approve prior to further use in clinical workflows. The system supports automatic contouring of pre-defined structures from common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis. Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.