JLK-CTP is an image processing software that helps trained medical professionals analyze brain CT perfusion images. It automatically receives, processes, and visualizes dynamic CT perfusion datasets to calculate blood flow and volume parameters, aiding in the assessment of cerebral blood flow and tissue status in brain imaging.
Intended Use
JLK-CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform such as VMware and can be used to perform image viewing, processing, and analysis of CT perfusion images for the brain. Data and images are acquired through DICOM compliant imaging devices. The software provides both viewing and analysis capabilities for dynamic imaging datasets obtained through CT Perfusion protocols, including calculation of CT perfusion parameters associated with tissue flow and blood volume.
Technology
The device is software designed to analyze CT perfusion images by calculating volumes of reduced cerebral blood flow and delayed Tmax areas. It interfaces with DICOM-compliant devices or PACS servers to receive images, automatically analyzes head CT perfusion images, and generates perfusion parameter maps related to tissue blood flow and volume, which are stored as DICOM data. It runs on standard or virtual computers within hospital networks and is protected by firewalls.
Performance
Performance validation and software verification demonstrated that JLK-CTP accurately calculates reduced blood flow and delayed Tmax tissue volumes with results substantially equivalent to the predicate device iSchemaView RAPID (K121447). Testing included software functionality, risk management, cybersecurity, verification, and validation, showing the device meets acceptance criteria and is reliable and accurate for clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/28/2024
1 month - 2
FDA Approval
10/16/2024
Other devices from JLK, Inc.
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