1. Introduction
Welcome to ALTICIAN Spine (“Application”, “we”, “us”, or “our”). By accessing or using this Application, you agree to be bound by these Terms of Use. If you do not agree, do not use the Application. This Application is operated by Altician Inc., based in the Republic of Korea.2. Description of Service
ALTICIAN Spine is a browser-based tool for visualizing MRI DICOM images in 3D. It optionally integrates with a locally installed AI helper application (ALTICIAN Spine Helper) for automated spinal structure segmentation using deep learning models (nnU-Net / SpinEPS).3. Regulatory Classification & Intended Use
THIS APPLICATION IS NOT A MEDICAL DEVICE. Under the IMDRF (International Medical Device Regulators Forum) Software as a Medical Device (SaMD) framework, this Application is classified as a non-SaMD research tool. It has not been cleared, approved, or certified by any regulatory authority, including but not limited to:- FDA (United States) — not 510(k) cleared, not De Novo authorized, not PMA approved
- EU MDR / CE (European Union) — not CE marked under Regulation (EU) 2017/745
- MFDS (Republic of Korea) — not approved under the Medical Devices Act
- PMDA (Japan), TGA (Australia), or any other national regulatory body
- Clinical diagnosis or screening
- Treatment planning or surgical guidance
- Any medical decision-making that affects patient care
- Use as a substitute for certified PACS, diagnostic imaging, or clinical decision support systems
4. AI-Generated Output Limitations
The AI segmentation feature (via ALTICIAN Spine Helper) uses deep learning models that:- Have not been validated through clinical trials or regulatory review processes
- May produce inaccurate, incomplete, or misleading segmentation results
- Were trained on limited datasets and may not generalize to all patient populations, MRI sequences, or scanner manufacturers
- Are not developed in accordance with IEC 62304 (Medical Device Software Lifecycle) or ISO 14971 (Risk Management)
5. Intended Users
This Application is intended for healthcare professionals, medical researchers, and educational users who understand the limitations of non-certified visualization and AI analysis tools. Users are expected to exercise independent professional judgment and not rely solely on the Application’s output.6. Local Processing & Data Responsibility
All DICOM image processing occurs locally on your computer. No patient data is transmitted to external servers. You are solely responsible for:- Ensuring compliance with your institution’s data governance policies
- Compliance with applicable regulations (HIPAA, GDPR, PIPA, or other local privacy laws)
- Proper handling and disposal of patient data on your local machine
- Clearing cached data (IndexedDB) as required by your institutional policies
7. EU AI Act Considerations
Under the EU Artificial Intelligence Act (Regulation (EU) 2024/1689), AI systems intended for medical purposes may be classified as high-risk. This Application is provided for research and educational use only and is not placed on the EU market as a medical AI system. Should regulatory classification change in the future, these Terms will be updated accordingly.8. Intellectual Property
The Application, including its design, source code, and content, is owned by Altician Inc.. “ALTICIAN” name and branding are our property. You may not copy, modify, or distribute any part of the Application without written permission.9. Open Source Components
This Application incorporates open-source software components (Cornerstone3D, VTK.js, React, SpinEPS, nnU-Net, and others). Each component is subject to its respective license. See the About dialog for full attribution.10. Acceptable Use
You agree NOT to:- Use the Application for clinical diagnosis, treatment planning, or patient care decisions
- Represent or market the Application as a cleared or approved medical device
- Use the Application for any illegal purpose
- Attempt to reverse engineer or decompile the Application (except as permitted by applicable law)
- Use the Application to create a competing product or service
- Remove or alter any proprietary notices, warnings, or disclaimers
11. Disclaimer of Warranties
THE APPLICATION IS PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. WE DO NOT WARRANT THAT THE APPLICATION WILL BE UNINTERRUPTED, ERROR-FREE, OR THAT ANY RESULTS — INCLUDING AI-GENERATED SEGMENTATION, MEASUREMENTS, OR VISUALIZATIONS — WILL BE ACCURATE, COMPLETE, OR SUITABLE FOR ANY PURPOSE.12. Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES ARISING FROM YOUR USE OF THE APPLICATION, INCLUDING BUT NOT LIMITED TO: CLINICAL DECISIONS MADE BASED ON INFORMATION DISPLAYED BY THE APPLICATION; MISDIAGNOSIS OR DELAYED DIAGNOSIS; DATA LOSS; OR ANY HARM TO PATIENTS, CLINICIANS, OR THIRD PARTIES.13. Assumption of Risk
By using this Application, you expressly acknowledge and agree that:- AI-generated analysis may be incomplete, inaccurate, or clinically misleading
- The Application has not undergone clinical validation or regulatory review
- You assume all risk associated with the use of visualization and segmentation results
- Results do not constitute medical advice, and no physician-patient relationship is created