MAGNETOM Amira; MAGNETOM Sempra
Siemens Medical Solutions USA Inc.MAGNETOM Amira and MAGNETOM Sempra are magnetic resonance imaging (MRI) systems designed to produce detailed images and spectra of the head, body, and extremities. They include advanced AI-powered image reconstruction features such as Deep Resolve Boost and Deep Resolve Sharp, which enhance image quality and sharpness. These systems assist clinicians by providing faster, higher-quality images to improve diagnosis and guide interventions.
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 Amira and MAGNETOM Sempra with software syngo MR XA50M have new and modified hardware and software features compared to previous versions, including dedicated new coils and AI-driven image reconstruction algorithms such as Deep Resolve Boost and Deep Resolve Sharp, implemented on 1.5T and 3T MRI scanners. The AI networks were trained on thousands of 2D image slices covering a wide range of body regions to improve image sharpness and reduce scan time.
Performance
Performance testing included software verification and validation per FDA guidance, sample clinical images with new coils and pulse sequences, and bench tests measuring coil SNR, image uniformity, and heating. AI features were validated by metrics like PSNR, SSIM, and perceptual loss, and visual inspection in clinical settings involving 427 patients across prostate, abdomen, musculoskeletal regions and brain, confirming improved image quality and no adverse effects on anatomical accuracy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/1/2022
4 months - 2
FDA Approval
3/28/2023
Other devices from Siemens Medical Solutions USA Inc.
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