MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
Siemens Medical Solutions USA, Inc.The MAGNETOM Vida, Lumina, Aera, Skyra, Prisma, and Prisma fit are advanced magnetic resonance imaging (MRI) systems designed to produce detailed cross-sectional and spectroscopic images of the body, head, and extremities. Equipped with new hardware and software improvements including AI-based image reconstruction techniques, these systems help clinicians obtain high-quality images to assist in diagnosis and interventional procedures.
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, displaying the internal structure and/or function of head, body, or extremities. Contrast agents may be used. Images and spectra derived parameters assist in diagnosis. Also used in imaging during interventional procedures with MR compatible devices.
Technology
The devices consist of hardware and software updates from predicate devices, including modified host computers, measurement and reconstruction system (MaRS), new Flex Loop Large coil on Aera, and new/modified imaging features such as GRE_PC, Physio logging, Open Recon, MR Fingerprinting, and Deep Resolve Boost AI-based reconstruction for enhanced imaging quality.
Performance
Performance testing included software verification, validation, sample clinical image assessment, and coil performance bench tests. AI features Deep Resolve Boost and Deep Resolve Sharp were trained and validated on large datasets with quality metrics (PSNR, SSIM) and evaluated visually for image sharpness and artifact reduction. No clinical testing conducted, but sample clinical images and literature references support performance. All tests support substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/30/2023
4 months - 2
FDA Approval
10/23/2023
Other devices from Siemens Medical Solutions USA, Inc.
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