Ezra Flash
Ezra AI, Inc.Ezra Flash is a software device that improves the quality of MRI images of the head, abdomen, and pelvis by reducing noise using advanced neural network algorithms. It processes images from 1.5T and 3T Siemens and GE MRI scanners, helping clinicians get clearer images to support more accurate diagnoses without additional scanning time.
Intended Use
Image processing software used for image enhancement of MR images to reduce image noise in non-contrast MRI exams from 1.5T and 3T Siemens and GE scanners for patients over 18 years old; applicable sequences include Sagittal T1, Axial T2 and Axial Flair for the head, Axial T2 and Coronal T2 for the abdomen, Sagittal T2, Axial T2, and Coronal T2 for the pelvis.
Technology
Software as a Medical Device (SaMD) that enhances image quality by receiving DICOM-compliant non-contrast MR images acquired on 1.5T and 3T scanners. It applies a convolutional neural network-based algorithm using a cascade of filter banks with thresholding and scaling operations to reduce noise, outputting enhanced DICOM-compliant images for radiologists.
Performance
Performance testing demonstrated that Ezra Flash improves signal-to-noise ratio (SNR) by at least 5%, improves contrast-to-noise ratio (CNR) by greater than 0%, and shows improved perceived image quality with average Likert scale improvements of at least 0.5 points compared to original MR images. Testing confirmed the device meets design specifications and is safe and effective for clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/7/2024
4 months - 2
FDA Approval
1/2/2025
Other devices from Ezra AI, Inc.
- Ezra Flash2023 • 510K
- Ezra Plexo Software2020 • 510K
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