MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit

The MAGNETOM Sola, Altea, and Sola Fit with syngo MR XA51A software are advanced magnetic resonance imaging systems designed to produce detailed anatomical and functional images for diagnosis and interventional guidance across various body regions. These systems incorporate new hardware like the myExam 3D Camera for patient positioning, and software innovations such as myExam_Autopilot for simplified workflows, Open Recon Framework for third-party algorithm integration, myExam Angio Advanced Assist for peripheral angiography, and Beat Sensor for cardiac triggering, all validated through non-clinical performance data.

The MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit, operating with syngo MR XA51A software, are magnetic resonance diagnostic devices (MRDDs). Their purpose is to generate transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images, and spectra, displaying the internal structure and function of the head, body, or extremities. These systems can also produce other physical parameters derived from the acquired data and may be used with contrast agents depending on the region of interest; the information obtained, when interpreted by a trained physician, aids in diagnosis, and the systems can also support imaging during interventional procedures using MR-compatible devices. These devices introduce several new and modified hardware and software components. Key hardware includes the myExam 3D Camera, designed to assist radiographers with patient positioning. Software enhancements feature myExam_Autopilot for simplified brain and knee MRI examinations by less experienced users, and the Open Recon Framework, which allows the application of container-based, FDA-cleared third-party reconstruction algorithms. Modified software includes myExam Angio Advanced Assist for improved planning and execution of peripheral angiography, and Beat Sensor Cardiac triggering, a pilot tone-based physiological triggering technique adapted for cardiac MRI. The performance and safety of these features were evaluated through non-clinical testing, including software verification, validation, and adherence to various IEC and NEMA standards.

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. How does the image quality and diagnostic confidence achieved with myExam_Autopilot for brain and knee examinations compare to scans manually optimized by experienced MRI technologists?; What specific safeguards or validation processes are in place within the Open Recon Framework to ensure the integrity and performance of imported third-party FDA-cleared reconstruction algorithms?; Can the Beat Sensor Cardiac triggering technology maintain reliable performance across a spectrum of cardiac conditions, such as arrhythmias or tachycardia, and how does it compare to conventional ECG-gating in these scenarios?; What is the learning curve associated with the myExam 3D Camera, and what quantifiable impact does it have on reducing patient setup time or improving positioning accuracy?; How does the myExam Angio Advanced Assist feature account for patient-specific variations in circulation time to optimize contrast bolus timing for multi-station peripheral angiography?