Rapid Neuro3D
iSchemaView, Inc.Rapid Neuro3D is an AI-powered medical software that processes CT angiography scans to provide 3D and 2D visualizations of the brain's arterial blood vessels. It helps physicians confirm the presence or absence of identified lesions and assists in evaluation and treatment planning by simplifying image interpretation.
Intended Use
Rapid Neuro3D (RN3D) is an image analysis software for imaging datasets acquired with conventional CT Angiography (CTA) from the aortic arch to the vertex of the head, removing bone, tissue, and venous vessels to provide 3D and 2D visualization of the neurovasculature supplying arterial blood to the brain.
Technology
Rapid Neuro3D is a Software as a Medical Device (SaMD) module within the Rapid Platform that processes DICOM CTA images using pre-trained AI/ML models to segment and visualize neurovascular structures in 2D and 3D. It provides outputs such as rotational maximum intensity projections (MIPS), volume renders (VR), and curved planar reformations (CPR). The software can be installed on-premises or in a hybrid cloud configuration.
Performance
Performance testing included segmentation quality and accuracy assessments using 120 CTA cases for segmentation outputs and 50 CTA cases for accuracy against ground truth. Clinical experts confirmed high agreement (>98.6%) on output image quality and 0.89-0.97 Dice coefficients for vessel segmentation accuracy. Tests included data from multiple CT vendors and various patient demographics.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/28/2024
2 months - 2
FDA Approval
1/22/2025
Other devices from iSchemaView, Inc.
- Rapid ASPECTS (v3)2024 • 510K
- Rapid (6.0)2024 • 510K
- Rapid SDH2023 • 510K
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