Rapid
iSchema View Inc.Rapid by iSchemaView Inc. is a medical image processing software designed to help clinicians analyze CT and MRI images, including functional and dynamic datasets like CT Perfusion and diffusion-weighted MRI. It facilitates quick visualization, quantification, and interpretation of brain tissue changes often seen in acute stroke, helping physicians select patients for endovascular thrombectomy and assess cerebral hemodynamics. The software supports both standard and C-arm CT images and assists in managing complex imaging data efficiently, enhancing clinical workflow and patient care in neurological emergencies.
Intended Use
Rapid is an image processing software package to be used by trained professionals including physicians and medical technicians. It performs image viewing, processing, and analysis of functional and dynamic imaging datasets from CT, CT Perfusion, CTA, C-arm CT Perfusion and MRI for adult patients.
Technology
Rapid is DICOM-compliant software that processes images from multiple sources to visualize tissue perfusion, diffusion, and changes using functional and dynamic imaging data. It runs on standard servers or virtual platforms and supports secure networking. Modules include CT Perfusion, Diffusion Weighted Imaging, and Dynamic Analysis of time-contrast changes. It integrates with hospital systems for data transfer and supports analysis outputs for acute stroke management.
Performance
Comprehensive phantom validation and software verification/validation testing were conducted showing accurate perfusion imaging performance across conventional CT and C-arm CT scanners. Results showed small expected biases due to modality differences, with the device meeting all design requirements and standards for performance and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/2/2023
5 months - 2
FDA Approval
4/22/2024
Other devices from iSchema View Inc.
- Rapid RV/LV2023 • 510K
- Rapid2022 • 510K
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