Rapid
iSchema View Inc.Rapid is a medical image processing software that helps clinicians visualize and analyze tissue changes in CT and MRI images, particularly aiding in the selection of acute stroke patients for treatment. It uses AI/ML components to detect image artifacts and supports advanced imaging features such as perfusion, diffusion and dynamic contrast analysis.
Intended Use
Rapid is an image processing software package to perform image viewing, processing and analysis of CT and MR images for assisting in the selection of acute stroke patients with known intracranial artery occlusions.
Technology
Software runs on standard hardware or virtual platform, processes DICOM images from CT and MRI sources, provides visualization and quantification tools, applies AI/ML motion artifact filters, and supports integration with hospital networks via secure connections.
Performance
Clinical and bench testing demonstrated high sensitivity and specificity for motion artifact detection (AUC 0.95-0.96). Validation used multi-vendor image data with independent ground truth assessment, and software testing confirmed accurate image processing and parameter quantification.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2021
4 months - 2
FDA Approval
2/8/2022
Other devices from iSchema View Inc.
- Rapid2024 • 510K
- Rapid RV/LV2023 • 510K
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