Neuro.Al Algorithm
TeraRecon, Inc.The Neuro.AI Algorithm by TeraRecon, Inc. is an AI-powered medical imaging software that analyzes brain perfusion images acquired via CT or MRI. It processes dynamic imaging data to generate detailed maps of brain tissue blood flow and vascular structures, helping trained medical professionals assess brain perfusion and vascular health efficiently. The software outputs detailed parametric maps and visualization aids to support clinical diagnosis without replacing physician judgment.
Intended Use
The Neuro.AI Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians. The Neuro.AI Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application that runs on off-the-shelf hardware or cloud platform. It processes dynamic brain perfusion image data acquired with CT or MRI to calculate parameters related to brain tissue perfusion, vascular assessment, and tissue blood volume and produces various parametric maps and images for clinical review and diagnosis.
Technology
The Neuro.AI Algorithm processes static, functional, dynamic and derived imaging datasets acquired with CT or MRI to compute brain perfusion parameters including time to peak, mean transit time, blood volume and flow, and generates 2D/3D visualizations including rotational MIP images. It supports motion correction, ventricle segmentation, and outputs DICOM-compatible results viewable on multiple imaging platforms such as TeraRecon's iNtuition and Northstar systems or third-party PACS. The software can be deployed on Windows hardware or as a containerized application on cloud or local hardware.
Performance
Safety and performance were verified and validated through software testing per IEC 62304 and risk management per ISO 14971. All pre-defined acceptance criteria were met with no new or different safety or efficacy questions raised compared to the predicate device. Software test cases passed and performance testing confirmed equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/23/2020
7 months - 2
FDA Approval
11/6/2020
Other devices from TeraRecon, Inc.
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