SIS System
Surgical Information Sciences, Inc.The SIS System is a software tool that uses advanced machine learning and image processing to help surgeons, neurologists, and radiologists visualize critical brain structures in 3D. It assists in planning neurological procedures such as Deep Brain Stimulation by creating detailed anatomical models from MRI images and localizing implanted leads on post-operative CT images, improving accuracy and surgical outcomes.
Intended Use
SIS System is intended for use in viewing, presentation and documentation of medical imaging including image processing, fusion, and intraoperative planning for neurological procedures such as Deep Brain Stimulation Lead Placement.
Technology
Software only device using machine learning and image processing, with pre-trained deep learning neural network models trained on ultra-high resolution 7T MR images to provide patient-specific 3D anatomical models of brain structures.
Performance
Software verification and validation testing demonstrated that the updated SIS System performs as intended, matching the safety and effectiveness of its predicate device with repeated accuracy testing for segmentation, registration, lead localization and electrode orientation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/5/2023
27 days - 2
FDA Approval
5/2/2023
Other devices from Surgical Information Sciences, Inc.
- SIS System2024 • 510K
- SIS System (Version 5.6.0)2022 • 510K
- SIS System (Version 5.1.0)2021 • 510K
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