VitruvianScan (v1.0)
Perspectum LtdVitruvianScan (v1.0) by Perspectum Ltd is a software medical device designed to analyze MRI images to generate quantitative metrics and composite images for evaluating body fat and muscle composition. It assists trained healthcare professionals by providing non-invasive diagnostic information that supports clinical decisions regarding patient health and wellness.
Intended Use
Software medical device intended to assist trained healthcare professionals in the non-invasive evaluation of body fat and muscle composition from MRI medical image data.
Technology
Standalone post-processing software applied to MRI images acquired from compatible scanners (GE, Siemens, Philips) at 1.5T and 3T field strengths. Uses secure data transfer followed by image processing by trained analysts to produce quantitative metrics and composite images.
Performance
Performance testing demonstrated the device is safe and effective with consistent metric repeatability and reproducibility across different scanner manufacturers (Siemens, GE, Philips) and field strengths (1.5T, 3T). Testing included unit, integration, system verification and validation, user acceptance, inter-operator and intra-operator variability, and comparison with predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/1/2024
3 months - 2
FDA Approval
10/2/2024
Other devices from Perspectum Ltd
- LiverMultiScan v5 (LMSv5)2022 • 510K
- Hepatica v1 (Hepatica v1.0.0)2021 • 510K
- LiverMultiScan2020 • 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.