BoneMRI is a software application that enhances MRI images to improve visualization of bone structures in the pelvic region, including the sacrum, hip bones, and femoral heads. It processes 3D MRI scans using a convolutional neural network algorithm to create enhanced images that help radiologists and orthopedic surgeons in assessing bone morphology and radiodensity without needing CT scans.
BoneMRI is an image processing software used for image enhancement in MRI images to visualize bone structures in the pelvic region with enhanced contrast to surrounding soft tissue.
BoneMRI is a standalone software running on Linux that processes 3D gradient echo MRI scans using a convolutional neural network to generate 3D tomographic radiodensity contrast images (BoneMRI images) enhancing bone structures. Output images are DICOM format for clinical viewing.
Performance testing included software verification and validation plus retrospective clinical studies on 61 patient datasets comparing BoneMRI with CT scans, demonstrating accurate reconstruction of 3D bone morphology and radiodensity with clinically acceptable error margins, supporting safe and effective use.
No predicate devices specified
Submission
8/21/2020
FDA Approval
12/22/2021
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