CerebralGo Plus
Yukun (Beijing) Technology Co., LtdCerebralGo Plus is a software package designed for trained medical professionals to view and process CT Angiography images of the head and neck. It helps visualize large vessels from adult CTA scans to support clinical decisions, although it is not intended for primary diagnostic use. The software integrates with standard DICOM-compliant imaging devices and hospital systems to facilitate image management and processing.
Intended Use
An image processing software package for viewing and processing CT Angiography datasets acquired from DICOM compliant imaging devices, used by trained professionals. Not intended for primary diagnostic use.
Technology
Runs on standard off-the-shelf hardware, interoperates with DICOM compliant devices (PACS, CT scanners), provides image viewing, processing, and manipulation functions for CTA images, mainly visualizing large vessels in head and neck CT Angiography.
Performance
Algorithm validation was performed using 141 US-collected CTA images from diverse demographics and equipment. Comparison against reference standards from three radiologists showed a Dice coefficient of 0.942 and 95% Hausdorff Distance of 3.692, indicating high accuracy and consistency across sites and patient groups.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/20/2021
1 year, 3 months - 2
FDA Approval
4/13/2023
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