LiverSmart is a software that automatically analyzes MRI images of the liver to measure both liver iron concentration and liver fat content. It processes images according to established protocols and generates a comprehensive report that assists clinicians in diagnosing and monitoring liver conditions such as iron overload and fatty liver disease, supporting treatment decisions and research.
Intended Use
For the measurement of R2 and iron concentration in the liver from MRI scans; for quantitative measurement of triglyceride fat fraction in MR images of the liver (volumetric liver fat fraction).
Technology
LiverSmart integrates two cleared software tools, HepaFat-AI and FerriSmart, to automatically analyze MRI liver images and generate a consolidated report combining volumetric liver fat fraction, proton density fat fraction, steatosis grade, and liver iron concentration. It uses convolutional neural networks for image analysis and algorithms for quality checks and parameter conversions.
Performance
Performance testing confirms that LiverSmart detects image acquisition anomalies and prevents erroneous analysis, producing results identical to the predicate HepaFat-AI and FerriSmart devices. Risk analysis and verification testing demonstrate that performance requirements are met, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/2/2021
27 days - 2
FDA Approval
12/29/2021
Other devices from Resonance Health Analysis Services Pty Ltd
- HepaFatSmart (V2.0.0)2023 • 510K
- HepaFat-AI2020 • 510K
- FerriSmart Analysis System2018 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.