# K212915: MVision AI Segmentation

- Pathway: 510(k) (Traditional)
- Applicant: MVision AI
- Decided: May 3, 2022 after 232 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 113 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181572: Workflow Box, Mirada Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K241490: Contour+ (MVision AI Segmentation) (2024), 0 descendants of its own

## Indications for use
MVision AI Segmentation is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT images using machine learning based algorithms. The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows. The system creates initial contours of pre-defined structures of common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis in adult patients. MVision AI Segmentation is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.

Source page: https://510kreport.com/device/K212915
Methodology: https://510kreport.com/methodology