MAGNETOM Sola; MAGNETOM Altea
Siemens Medical Solutions USA, Inc.MAGNETOM Sola and MAGNETOM Altea are advanced MRI systems designed to produce high-quality transverse, sagittal, coronal, and oblique cross-sectional images. They include AI-powered features such as Deep Resolve Boost and Deep Resolve Sharp for enhanced image reconstruction, improving image quality and diagnostic accuracy. These systems assist clinicians in diagnosis by providing improved visualization of internal structures and functions across the head, body, and extremities, and can also be used during MR-guided 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, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. These images and/or spectra and the physical parameters derived when interpreted by a trained physician yield information that may assist in diagnosis. The system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Technology
MAGNETOM Sola and MAGNETOM Altea with software syngo MR XA61A consist of new and modified software and hardware, including host computers, MaRS computer (for MAGNETOM Sola), myExam 3D Camera, and new AI-powered image reconstruction features such as Deep Resolve Boost (HASTE and EPI Diffusion), GRE_PC pulse sequences, and Complex Averaging. The system performs MRI scanning and reconstruction using modified OpenRecon framework with SAR adaptive protocols for several body regions.
Performance
Performance testing included software verification and validation of new and modified features, sample clinical images comparing image quality to predicate device, physiologging verification, and validation of new hardware components like myExam 3D Camera and Implant Suite. AI features Deep Resolve Boost and Deep Resolve Sharp were trained and validated on large datasets spanning over 1,000,000 MRI slices covering a broad range of body parts and imaging parameters. Quality metrics PSNR, SSIM, and perceptual loss showed improved image quality and denoising. No dedicated clinical studies were conducted but clinical publications support the effectiveness of key AI features.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/21/2023
4 months - 2
FDA Approval
12/22/2023
Other devices from Siemens Medical Solutions USA, Inc.
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