ANDI is a software tool that processes diffusion-weighted MRI brain scans to create 3D maps of white matter tracts. It helps neurologists and radiologists by providing detailed visualization and measurements of brain white matter structures, serving as an adjunct tool for patient assessment without making diagnoses.
Intended Use
ANDI is intended for display of medical images and other healthcare data, including processing diffusion-weighted MRI sequences into 3D maps representing white matter tracts; the output is for measurement of brain white matter tracts only and not for diagnosis.
Technology
ANDI processes diffusion-weighted and T1-weighted MRI using local and global reconstruction algorithms (modeling, tractography, white matter bundling) to extract and quantify brain white matter bundles; it uses a proprietary white matter bundles atlas and outputs DICOM-encapsulated PDF reports for adjunctive clinical use.
Performance
Non-clinical performance testing was performed according to recognized standards; software was validated and shown to meet performance criteria, ensuring device functions as intended and equivalence to predicate devices; no clinical studies were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2023
3 months - 2
FDA Approval
7/25/2023
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