Intended Use

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.

Technology

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

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/21/2020

    1 year, 4 months
  • 2

    FDA Approval

    12/22/2021

Other devices from MRIguidance B.V

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