MAGNETOM Terra; MAGNETOM Terra.X
Siemens Medical Solutions USA, Inc.MAGNETOM Terra and MAGNETOM Terra.X are advanced 7 Tesla MRI systems by Siemens designed for capturing high-quality magnetic resonance images primarily of the head and extremities. Equipped with enhanced hardware and AI-based software (Deep Resolve Boost, Sharp, and RxE), these devices improve image quality and reconstruction speed, helping radiologists obtain clearer diagnostic images faster, thus supporting better patient diagnosis and care.
Intended Use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) producing cross-sectional images and physical parameters of the head or extremities. It also produces Sodium images for the head and Phosphorus spectroscopic images or spectra for whole body except head to assist diagnosis when interpreted by a trained physician.
Technology
MAGNETOM Terra and Terra.X integrate new and modified hardware components, including advanced transmit coils with 8Tx/32Rx channels for improved B1 homogeneity and SAR management. Software enhancements include AI-driven image reconstruction algorithms (Deep Resolve Boost, Sharp, and RxE), static B1 shimming, compressed sensing pulse sequences, and dynamic parallel transmission, all designed to improve image quality, reduce scan time, and enable advanced diagnostic imaging.
Performance
Performance testing included validation of new and modified hardware and software through clinical image comparisons, software verification and validation, electrical safety, and electromagnetic compatibility testing. AI features underwent rigorous training with large datasets and were evaluated by quality metrics such as PSNR and SSIM, plus clinical evaluations by trained radiologists showing no misinterpretation or artifact introduction. Clinical studies confirmed safe nerve stimulation thresholds and overall performance equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/3/2023
7 months - 2
FDA Approval
3/22/2024
Other devices from Siemens Medical Solutions USA, Inc.
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