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# Surgical Info Sciences 510(k) for Brain Visualization
- URL: https://www.fdaweb.com/surgical-info-sciences-510-k-for-brain-visualization/
- Published: 2021-04-05T12:00:00.000Z
- Updated: 2026-09-14T16:53:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149040

FDA has cleared a Surgical Information Sciences 510(k) for an updated algorithm with new visualization capabilities for its SIS System. The device was previously cleared for visualizing brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a deep brain stimulation (DBS) procedure, and visualizing the location of the STN relative to the implanted DBS leads, including identification of the lead contacts. The company says the updated algorithm and new capabilities improve features of the SIS System, including:

- Updated algorithm based on deep learning models to improve brain image segmentation
- Addition of functionality to determine the orientation of a directional DBS lead