Ezra Flash
Ezra AI, Inc.Ezra Flash is a software tool that uses AI (convolutional neural networks) to enhance brain MRI images by reducing noise. It supports 3-Tesla Siemens and GE MRI scanners for specific sequences, providing clearer images to assist radiologists in diagnosis without altering the original images.
Intended Use
Ezra Flash is an image processing software used for image enhancement of MR images to reduce image noise from non-contrast 3-Tesla Siemens and GE head MRI scans.
Technology
Ezra Flash uses a convolutional neural network-based algorithm to enhance image quality by reducing noise on DICOM non-contrast MR images from 3-Tesla Siemens and GE scanners. It outputs DICOM-compliant enhanced images without altering the original, operating as a software-only device on Linux-compatible systems.
Performance
Performance testing showed that Ezra Flash improved signal-to-noise ratio (SNR) by at least 5%, contrast-to-noise ratio (CNR) by greater than 0%, and had clinically acceptable image quality improvements based on Likert scale ratings. The testing demonstrated safe and effective performance according to software verification and validation plans.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/31/2023
2 months - 2
FDA Approval
4/13/2023
Other devices from Ezra AI, Inc.
- Ezra Plexo Software2020 • 510K
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