SubtleHD (1.x)
Subtle Medical, Inc.SubtleHD (1.x) is an AI-based image processing software designed to enhance MRI images from any body part. It improves image quality by reducing noise and increasing sharpness, helping radiologists obtain clearer images without changing the original scan process. This facilitates improved diagnostic confidence and visualization of anatomical structures.
Intended Use
SubtleHD is an image processing software that can be used for image enhancement of all body parts MRI images. It can be used for noise reduction and increasing image sharpness.
Technology
Software as a Medical Device (SaMD) that enhances MRI images using a convolutional neural network based filtering algorithm. It applies a cascade of filter banks including thresholding and scaling operations, combined noise reduction, and sharpening filters including nonlocal mean denoising and unsharp masking. Operates on DICOM files to produce enhanced images that coexist with original images.
Performance
Performance testing included software verification and validation, standalone image quality metric testing (L1 loss, SSIM, PSNR), performance validation on retrospective clinical MRI data across multiple anatomies and protocols, and a reader study with board-certified radiologists. Results demonstrated statistically significant improvements in noise reduction, sharpness, and image quality without introducing artifacts. Testing covered pediatric and adult populations, various field strengths, and multiple vendors.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/15/2024
4 months - 2
FDA Approval
2/12/2025
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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