JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.
Intended Use
Image processing software for viewing, processing, and analysis of diffusion-weighted (DWI) and perfusion-weighted imaging (PWI) brain MRI images, used by trained professionals.
Technology
Processes DWI and PWI images from MRI scanners by automatically receiving DICOM-compliant images, calculating diffusion and perfusion parameters such as Apparent Diffusion Coefficient (ADC), Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), Mean Transit Time (MTT), and time-to-peak (Tmax). The software stores results back into DICOM format and provides a user interface for viewing and analysis.
Performance
Extensive performance validation and software verification testing demonstrated that JLK-PWI reliably and accurately calculates key diffusion and perfusion parameters. Results are substantially equivalent to those from the legally marketed predicate device RAPID (K121447), supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/9/2024
1 month - 2
FDA Approval
11/4/2024
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