SubtleMR (2.3.x)
Subtle Medical Inc.SubtleMR (2.3.x) is an AI-powered software that improves MRI images by reducing noise or enhancing sharpness. It supports MRI scans of various body regions such as head, spine, abdomen, and more. This helps clinicians obtain clearer images, potentially improving diagnostic accuracy without additional scans or equipment.
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, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increase image sharpness for head MRI.
Technology
SubtleMR uses a convolutional neural network-based algorithm that applies fixed parameters as a nonlinear filter for noise reduction or sharpness enhancement on standard MRI images. It processes images input as DICOM or ISMRMRD format without a user interface, supporting 1.2T to 3T MRI scanners.
Performance
The device passed performance tests demonstrating improved signal-to-noise ratio by at least 5% in noise reduction mode and improved anatomical structure sharpness in at least 90% of datasets for sharpness enhancement, supported by a retrospective clinical data study and software validation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/5/2022
5 months - 2
FDA Approval
5/11/2023
Other devices from Subtle Medical Inc.
- AiMIFY (1.x)2024 • 510K
- SubtleSYNTH (1.x)2024 • 510K
- SubtlePET2021 • 510K
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