FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The SIS System by Surgical Information Sciences, Inc. is an advanced software tool that assists clinicians, including surgeons, neurologists, and radiologists, by providing detailed visualization and 3D models of specific brain structures. It uses machine learning models trained on high-resolution MR images to aid in planning and guiding deep brain stimulation surgeries and other neurological procedures, helping to precisely locate key brain areas and implanted leads for improved surgical outcomes.

FDA #
K241083
Product Code
QIH

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.

FDA #
K230977
Product Code
QIH

The SIS System version 5.6.0 is a medical imaging software that helps surgeons, neurologists, and radiologists visualize specific brain structures in 3D to assist with planning neurological surgeries such as deep brain stimulation. It uses advanced image processing and machine learning techniques to create patient-specific anatomical models from MRI and CT images, improving precision during surgical interventions.

FDA #
K223032
Product Code
QIH
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