iSchemaView RAPID
iSchemaView, Inc.iSchemaView RAPID is a software package that helps medical professionals view and analyze CT and MRI images, particularly to evaluate stroke patients for endovascular thrombectomy. It provides advanced image processing for perfusion, diffusion, and angiography to aid clinical decision-making.
Intended Use
Image processing software package to perform image viewing, processing and analysis of CT Perfusion, CT Angiography, and MRI including Diffusion Weighted MRI data, aimed at assisting physicians in acute stroke patient selection for endovascular thrombectomy.
Technology
Software-only image processing system that processes DICOM images from CT and MRI scanners, providing visualization and quantitative analyses of tissue perfusion, diffusion, and vascular density. Runs on standard or virtualized servers, integrates with hospital networks securely, and supports modules for CT Angiography, Diffusion Weighted Imaging, and dynamic contrast-enhanced imaging.
Performance
Performance validation and software verification testing demonstrated that RAPID accurately processes and supports the analysis of CT and MRI images for tissue evaluation, meeting design requirements. It complies with relevant standards including EN ISO 14971:2012, IEC 62304:2015, IEC 62366:2015, and NEMA DICOM standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/6/2018
4 months - 2
FDA Approval
12/27/2018
Other devices from iSchemaView, Inc.
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