SubtleMR
Subtle Medical, Inc.SubtleMR is a software tool that enhances MRI images by reducing noise or increasing sharpness using a convolutional neural network algorithm. It works with various MRI scans of the head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal areas to help radiologists obtain clearer images for better interpretation and diagnosis.
Intended Use
SubtleMR is an image processing software that can be used for image enhancement in MRI images to reduce image noise or increase image sharpness for various anatomical areas including head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI.
Technology
SubtleMR is a Software as a Medical Device (SaMD) using a convolutional neural network-based algorithm to improve MRI image quality by reducing noise or enhancing sharpness. It operates on DICOM-compliant MRI images from 1.2T, 1.5T, and 3T scanners, producing enhanced output images. It has no user interface and is controlled via DICOM Series Description or command line/environment variable.
Performance
Performance testing included software verification and validation as well as a retrospective clinical study demonstrating improved image quality via noise reduction or sharpness enhancement. Noise reduction showed a ≥5% improvement in signal-to-noise ratio without loss of small structure visibility; sharpness enhancement improved structure thickness and boundary sharpness in ≥90% of cases. Testing demonstrated substantial equivalence to predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/27/2020
4 months - 2
FDA Approval
2/26/2021
Other devices from Subtle Medical, Inc.
- AiMIFY (1.x)2024 • 510K
- SubtleSYNTH (1.x)2024 • 510K
- SubtleMR (2.3.x)2023 • 510K
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