SubtleMR
Subtle Medical, Inc.SubtleMR is a software device that enhances MRI images by reducing noise or increasing image sharpness using a convolutional neural network algorithm. It supports MR images from 1.2, 1.5, and 3 Tesla scanners and helps radiologists by improving image quality without requiring a user interface. This enhancement assists clinicians in better visualization of anatomical details for diagnosis and treatment planning.
Intended Use
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck and knee MRI, or increase image sharpness for non-contrast enhanced head MRI.
Technology
SubtleMR is software as a medical device (SaMD) that uses a convolutional neural network-based algorithm to enhance MRI images by reducing noise or increasing sharpness. The algorithm works as a fixed nonlinear filter with parameters chosen based on the enhancement type. The software operates on DICOM compliant images from standard MRI scanners and outputs enhanced images stored alongside original images.
Performance
Performance testing included software verification and validation, and a retrospective clinical data study demonstrating improved image quality by increasing signal-to-noise ratio by at least 5% for noise reduction, and improving anatomical structure sharpness or thickness in at least 90% of cases for sharpness increase. Both acceptance criteria were met, supporting substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/24/2019
2 months - 2
FDA Approval
9/16/2019
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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