MAGNETOM Avanto fit; MAGNETOM Skyra fit
Siemens Medical Solutions USA, Inc.MAGNETOM Avanto fit and MAGNETOM Skyra fit are advanced MRI systems designed by Siemens that provide high-quality magnetic resonance imaging. These devices produce detailed cross-sectional images as well as spectroscopic data of the head, body, and extremities, helping physicians diagnose a variety of conditions and support imaging during interventional procedures with MR compatible devices.
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. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM 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 Avantofit and MAGNETOM Skyrafit devices consist of new and modified hardware and software components compared to predicate devices. Hardware includes new coils (Flex Loop Large, UltraFlex Large 18, UltraFlex Small 18, Contour 24), new and modified host computer systems, and a Measurement and Reconstruction System (MaRS) computer. Software enhancements include new pulse sequences (GRE_PC), physiologging functionality for certain sequences, an Open Recon Framework for image reconstruction, and modified application features such as myExam Angio Advanced Assist.
Performance
Performance testing included software verification and validation, assessment of sample clinical images comparing new or modified features to predicate devices, and bench testing of local coils for signal-to-noise ratio (SNR), image uniformity, and heating measurements. The testing demonstrated that the new features and hardware perform safely and effectively, bearing an equivalent safety and performance profile to predicate devices. No new clinical tests were conducted, but clinical publications and sample images supported functionality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/17/2023
2 months - 2
FDA Approval
11/14/2023
Other devices from Siemens Medical Solutions USA, Inc.
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