MAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.MAGNETOM Cima.X Fit is a magnetic resonance imaging (MRI) system by Siemens that produces detailed cross-sectional images of the body, head, or extremities. It incorporates AI-driven software features to enhance image quality and accelerate scanning, helping clinicians diagnose by providing clearer and faster MRI scans.
Intended Use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Technology
MAGNETOM Cima.X Fit consists of new and modified hardware (3D camera, host computers, gradient coil, body coil, etc.) and software features, including new AI-driven reconstruction algorithms (Deep Resolve Boost HASTE, Deep Resolve Boost EPI Diffusion) and improved imaging sequences to improve image quality and scanning speed. It operates similarly to the cleared predicate device MAGNETOM Vida.
Performance
Performance testing included software verification and validation of new or modified AI-based reconstruction features, bench testing of hardware components for safety and image quality, and analysis of clinical images comparing new features to predicate. AI features were trained and validated on large datasets covering multiple body regions and evaluated using metrics like PSNR and SSIM. Clinical publications supporting AI accelerated sequences were also cited.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/8/2023
5 months - 2
FDA Approval
2/29/2024
Other devices from Siemens Medical Solutions USA, Inc.
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