Intended Use

iSchemaView's Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. It is used for viewing and analysis of images acquired using CT/CBCT Perfusion, CT Angiography, and MRI, to assist in selection of acute stroke patients and provide further analysis of functional and dynamic medical imaging datasets.

Technology

Rapid processes DICOM images from CT and MRI scanners, performing automated analysis such as perfusion, diffusion, and vessel density calculations using multiple software modules. It can run on standard or virtual servers, integrates via PACS, and supports secure network protocols. The platform is modular, enabling multiparametric analysis and data management for stroke and neuroimaging workflows.

Performance

The Rapid platform was validated via software verification and validation as well as performance validation testing, including testing with phantom and clinical case data. These tests showed the software accurately represents key imaging parameters and meets design specifications. Regulatory conformance includes EN ISO 14971:2019, IEC 62304:2016, IEC 62366:2015, and DICOM compliance.

Predicate Devices

No predicate devices specified

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