MAGNETOM Viato.Mobile

The MAGNETOM Viato.Mobile is a 1.5 Tesla mobile magnetic resonance diagnostic device, utilizing syngo MR XA51A software, engineered to produce cross-sectional images and spectra for diverse diagnostic applications and to support imaging during interventional procedures. Its methodology incorporates minor hardware modifications and adaptations for mobile deployment, with its performance and safety validated through comprehensive non-clinical testing against recognized industry standards.

The MAGNETOM Viato.Mobile, equipped with software syngo MR XA51A, is a magnetic resonance diagnostic device (MRDD) designed to produce a variety of images including transverse, sagittal, coronal, and oblique cross-sections, as well as spectroscopic images and spectra. It is intended for visualizing the internal structure and function of the head, body, or extremities, and can derive other physical parameters from the acquired data. The system supports the use of contrast agents depending on the region of interest and, when interpreted by a trained physician, the information obtained assists in diagnosis. Furthermore, the MAGNETOM Viato.Mobile can be utilized for imaging during interventional procedures, provided MR compatible devices like in-room displays and MR Safe biopsy needles are used. This 1.5 Tesla system is specifically engineered as a mobile MR solution, enabling healthcare providers to relocate the MRI system to different locations to offer imaging services where needed. Its design includes minor hardware modifications, such as a modified cover, and adaptations for installation within a mobile trailer when compared to its predicate device, the MAGNETOM Sola Fit. The device's safety and effectiveness were assessed through non-clinical testing, which included performance bench tests on the modified hardware, verification and validation procedures, and comprehensive electrical safety and electromagnetic compatibility (EMC) tests on the complete system. The results of these tests demonstrated that the MAGNETOM Viato.Mobile performs as intended, establishing its operational integrity without the need for additional clinical studies for this particular submission.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific advantages or limitations of the "minor modified hardware" (cover and mobile adaptations) in the MAGNETOM Viato.Mobile in terms of image acquisition, patient comfort, or system durability in a mobile environment?; How does the mobility of the MAGNETOM Viato.Mobile impact the consistency of image quality and diagnostic performance across different deployment locations and potential variations in environmental conditions?; What were the quantitative results (e.g., Signal-to-Noise Ratio, image uniformity) from the performance bench tests on the modified hardware, and how do these compare to the MAGNETOM Sola Fit predicate device?; The system is indicated for imaging during interventional procedures with MR compatible devices; what specific types of interventional procedures and MR compatible devices have been validated or are particularly suited for use with the MAGNETOM Viato.Mobile?; Considering the syngo MR XA51A software platform, what specific imaging sequences or workflow optimizations are highlighted in the MAGNETOM Viato.Mobile to enhance its utility as a relocatable MRI service?