BoneMRI
MRIguidance B.VBoneMRI is an AI-powered software that enhances MRI images to better visualize bone structures in the pelvic and spine regions. It improves the contrast of bone relative to soft tissue to assist radiologists and orthopedic surgeons in assessing bone morphology and tissue radiodensity without replacing CT imaging. It supports clinical use in patients aged 12 and older and operates via hospital networks, ensuring data security.
Intended Use
BoneMRI is an image processing software used for image enhancement in MRI images to visualize bone structures with increased contrast compared to surrounding soft tissue in the pelvic and spine regions for patients 12 years and older.
Technology
The application analyzes 3D gradient echo MRI scans using a convolutional neural network-based image enhancement algorithm to generate 3D tomographic radiodensity contrast images called BoneMRI images. It runs as on-premise or managed cloud software integrated with DICOM systems and assigns Hounsfield Unit values to image voxels for bone visualization.
Performance
Validation using retrospective clinical data with 76 pelvic and 117 spine patients showed BoneMRI accurately reconstructs 3D bone morphology with mean cortical delineation error below 1 mm, tissue radiodensity deviation below 25 HU, and radiodensity contrast coefficient above 0.75. Testing included diverse subgroups by age, vendors, and BMI.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/25/2023
5 months - 2
FDA Approval
3/1/2024
Other devices from MRIguidance B.V
- BoneMRI v1.62023 • 510K
- BoneMRI2021 • 510K
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