Veuron-Brain-pAb3
Heuron Co., Ltd.Veuron-Brain-pAb3 is advanced software that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentration as an aid in diagnosing dementia. It automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, improving diagnostic accuracy and workflow efficiency.
Intended Use
Software for registration, fusion, display, and analysis of medical images from MRI and PET, aiding clinicians in assessment and quantification of pathologies from PET amyloid brain scans by calculating standard uptake value ratio (SUVR) in target regions.
Technology
Standalone software that loads DICOM and NIfTI format PET and MRI images, performs image overlay, automatic post-processing, calculates SUVR using a CNN segmentation algorithm trained on 3D brain MR images, and supports worklist and tracer options for beta amyloid PET tracers.
Performance
Software verification and validation testing was performed according to verification and validation processes, demonstrating that all system requirements have met acceptance criteria. No clinical testing was conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/5/2023
4 months - 2
FDA Approval
10/13/2023
Other devices from Heuron Co., Ltd.
- Heuron ICH2024 • 510K
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