StrokeViewer Perfusion
NICo-Lab B.V.StrokeViewer Perfusion is a software package designed to analyze dynamic brain CT perfusion scans to provide quantitative information about blood flow and volume in brain tissue. It aids medical professionals by visualizing perfusion maps and numerical data to assist in the evaluation of suspected ischemic stroke patients. The software supports clinicians by generating additional imaging data to inform diagnosis and treatment decisions without replacing clinical judgment.
Intended Use
StrokeViewer Perfusion is an image processing software package intended to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients. It is to be used by medical imaging professionals who analyze dynamic perfusion studies, including but not limited to physicians such as neurologists, and radiologists.
Technology
StrokeViewer Perfusion runs on standard or virtual computer platforms and analyzes dynamic brain CT perfusion imaging data (DICOM compliant). It calculates perfusion parameters including cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), Tmax, and arterial input function (AIF), producing parametric maps and volumetric measurements which are output as DICOM series and reports.
Performance
Performance testing included software validation and verification per FDA software guidance. Non-clinical bench testing using simulated datasets demonstrated that StrokeViewer Perfusion meets design requirements and correlates well with ground truth values. Risk management followed ISO 14971:2019 standards. Clinical data was not required for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2023
6 months - 2
FDA Approval
12/14/2023
Other devices from NICo-Lab B.V.
- HALO2020 • 510K
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