MAGNETOM Cima.X
Siemens Medical Solutions USA, Inc.MAGNETOM Cima.X is an advanced magnetic resonance imaging (MRI) system designed to produce detailed images and spectroscopic data of the head, body, and extremities. It incorporates new and modified hardware and software features including deep learning-based reconstruction methods to enhance image quality and speed, helping clinicians in diagnosis and interventional imaging procedures.
Intended Use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device 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 uses new and modified hardware and software including a 3D camera, upgraded host computers, enhanced gradient coil, and advanced software features like Deep Resolve Boost for image reconstruction, Physio logging, Open Recon, and pulse sequence MR Fingerprinting (MRF) to improve diagnostic capabilities and image quality.
Performance
Performance testing including software verification, validation, bench testing of hardware components, and image quality assessment was conducted. AI components such as Deep Resolve Boost were trained and validated on large datasets covering various body parts and imaging conditions, with visual ratings and quantitative metrics confirming image quality improvements and safety. No new clinical tests were conducted, but existing clinical publications support the features.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2023
6 months - 2
FDA Approval
12/18/2023
Other devices from Siemens Medical Solutions USA, Inc.
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