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Version: Research-v26.0

Introduction

Purpose

The purpose of this document is to provide instructions for the safe and effective use of the MySegmenter Research v26.0.

Scope

This document covers the usage and operation of the MySegmenter Research v26.0 and provides important information for users.

Indications for use

MySegmenter Research is a medical image segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended only for research or educational purposes; they must not be used for planning, medical analysis, or in the operating room.

The software is recommended for use by teachers and researchers in the healthcare or biomedical field, or by qualified medical professionals. The 3D models and replicas are to be utilized solely for research activities and educational purposes; they must not be used in any live medical application. The MR images have not been tested for craniomaxillofacial

Intended Patients

The MySegmenter Research v26.0 is not intended to be used on patients, it shall be only utilized for educational or research purposes.

Intended users

The MySegmenter Research v26.0 should only be used by educators, researchers, students or medical professionals, this includes:

  • Educators (Teachers): Faculty in healthcare or biomedical academic programs who use the 3D anatomical models generated from CT/MRI scans to teach anatomy, imaging interpretation, or segmentation concepts to students, without any patientspecific or clinical application.
  • Healthcare/Biomedical Researchers: Scientists, academic researchers, or graduate students studying segmentation algorithms, anatomical modeling techniques, or imaging workflows, using the software strictly for research investigations rather than for informing real patient care.
  • Qualified Medical Professionals (Research/Educational Capacity): Physicians, surgeons, or other credentialed clinicians who use the tool outside of direct patient care — for example, to explore anatomical variation, conduct academic studies, or support training and educational activities — but who are explicitly barred by the intended use from applying the models to treatment planning, diagnosis, or intraoperative use.